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Adverse Event Report

ELECTROMECH, INC. SENSOR PAD BED ALARM   back to search results
Lot Number 0696
Event Description

Staff found the pt on the floor. A bed alarm was in place but did not activate. Since 8/1/96 investigation indicates that there have been seven (7) other separate but similar incidents which have occurred where the bed alarm device did not activate properly. The product problem involves the bed alarm device either not alarming at all or the alarm activation is significantly delayed. In an actual test of a device that did malfunction, there was a 4 1/2 delay.

 
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Brand NameSENSOR PAD
Type of DeviceBED ALARM
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
ELECTROMECH, INC.
528 elm st
kearny NJ 07032
Device Event Key44123
MDR Report Key43153
Event Key40434
Report NumberMW1010077
Device Sequence Number1
Product CodeKMI
Report Source Voluntary
Report Date 10/07/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/17/1996
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date10/24/1996
Device LOT Number0696
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 10/17/1996 Patient Sequence Number: 1
#TreatmentTreatment Date
1,BED ALARM MODEL M1000, CLASS 2 POWER SUPPLY, MODEL,
2,EM 2525 M2-R,

Database last updated on January 06, 2009

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