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Adverse Event Report

DATEX-ENGSTROM DIV., INSTRUMENTARIUM CORP. DATEX-ENGSTROM ESTPR MODULE MULTIPARAMETER PATIENT MONITOR   back to search results
Model Number M-ESTPR-00-02
Event Date 01/01/1998
Event Type  Malfunction   Patient Outcome  Life Threatening;
Manufacturer Narrative

The device was investigated because it was reported that the spo2 reading displayed was 100% when the actual value determined by arterial blood gas analysis was 64%. There was no reported affect on the pt. In usa similar modules are used in the anesthesia environment in as/3 monitors. The module with the appropriate spo2 probe has been returned to the mfr. In thorough investigations no faults have been found in the module or in the probe. Co has collected info about the pt's condition and hosp practice. Based on the info and the investigations co has made, co cannot determine what has caused the problem. The reported product problem is an individual case and co has not found any fault from the device. No other actions will be taken unless co receives some new info.

 
Event Description

The spo2 reading displayed on the monitor was 100% when the actual valve determined by arterial blood gas analysis was 64% the monitor was used in the intensive care unit for monitoring a pt who was born in 1934. There was no reported affect on the pt.

 
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Brand NameDATEX-ENGSTROM ESTPR MODULE
Type of DeviceMULTIPARAMETER PATIENT MONITOR
Baseline Brand NameDATEX-ENGSTROM ESTPR MODULE
Baseline Generic NameMULTIPARAMETER PATIENT MONITOR
Baseline Catalogue NumberM-ESTPR
Baseline Model NumberM-ESTPR-00-02
Baseline Device FamilyDATEX-ENGSTROM NESTPR MODULES
Baseline Device 510(K) NumberK953175
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed02/06/1997
Manufacturer (Section F)
DATEX-ENGSTROM DIV., INSTRUMENTARIUM CORP.
p.o. box 900
datex-engstrom
FINLAND FIN-00310
Manufacturer (Section D)
DATEX-ENGSTROM DIV., INSTRUMENTARIUM CORP.
p.o. box 900
datex-engstrom
FINLAND FIN-00310
Manufacturer (Section G)
GE HEALTHCARE FINLAND OY
kuortaneenkatu 2
helsinki
FINLAND FIN-00510
Manufacturer Contact
rauno ruoho
teollisuuskatu 27
helsinki  
FINLAND   00510
358 103 943624
Device Event Key157094
MDR Report Key161331
Event Key151622
Report Number9610105-1998-00003
Device Sequence Number1
Product CodeDRT
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Service Personnel
Type of Report Initial
Report Date 03/30/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/04/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberM-ESTPR-00-02
Device Catalogue NumberM-ESTPR
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/18/1998
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/18/1998
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/1997
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Database last updated on February 28, 2009

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