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Adverse Event Report

AGILENT TECHNOLOGIES, INC. V24/26 COMPONENT MONITORING SYSTEM BEDSIDE MONITOR   back to search results
Model Number M1205A
Event Type  Death   Patient Outcome  Death;
Event Description

The customer reported that neither the bedside monitor nor the central station alarmed while the pt was losing blood (due to a disconnection between the pt and the dialysis machine).

 
Manufacturer Narrative

The customer's report is consistent with the alarms being suspended. When the bedside alarms are suspended, the central station will also not alarm. H3: agilent was not able to make contact with the customer to evaluate the m1205a bedside monitor. Agilent technologies is still investigating this event and will send a follow-up report to the fda when the investigation is complete.

 
Manufacturer Narrative

An agilent customer engineer met with the customer to determine if there needed to be add'l training provided. The customer agreed to have agilent reconfigure all of their bedside monitors to "3 minute alarm suspend" from the currently configured "indefinite suspend. " a. 1. -a. 4. Pt info: the customer did not provide pt info. B. 2. Date of death: the customer did not provide pt info. B. 2. Date of death: the customer did not provice the date of death. B. 3. Date of event: the customer did not provide the date of event. D. 6. Serial number: it was one of 12 bedside monitors in the serial number range of 3902a45268 through 3902a45279. H. 4. Because the customer did not provide the serial number of the m1205a bedside monitor, its mfg date could not be determined.

 
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Brand NameV24/26 COMPONENT MONITORING SYSTEM
Type of DeviceBEDSIDE MONITOR
Baseline Brand NameV24/26 COMPONENT MONITORING SYSTEM
Baseline Generic NameBEDSIDE MONITOR
Baseline Catalogue NumberM1205A
Baseline Model NumberM1205A
Other Baseline ID NumberBEDSIDE MONITORING SYSTEMS
Baseline Device FamilyCOMPONENT MONITORING SYSTEM
Baseline Device 510(K) NumberK950821
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed04/01/1995
Manufacturer (Section F)
AGILENT TECHNOLOGIES, INC.
3000 minuteman rd.
andover MA 01810 1099
Manufacturer (Section D)
AGILENT TECHNOLOGIES, INC.
3000 minuteman rd.
andover MA 01810 1099
Manufacturer Contact
jean schubach
3000 minuteman road
andover , MA 01810-1099
(978) 659 -3956
Device Event Key331750
MDR Report Key342414
Event Key322451
Report Number1218950-2001-00163
Device Sequence Number1
Product CodeDRT
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation Nurse
Type of Report Followup,Initial
Report Date 06/15/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberM1205A
Device Catalogue NumberM1205A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/15/2001
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on January 06, 2009

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