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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX 3 WIRE (SNAP) AAMI ECG LEAD SET

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PHILIPS MEDICAL SYSTEMS HEARTSTART MRX 3 WIRE (SNAP) AAMI ECG LEAD SET Back to Search Results
Model Number M3526A
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Event Description

The customer reported a failure of a m3526a, ecg lead set 3 lead. There was no reported patient incident/injury.

 
Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

 
Event Description

The customer reported an intermittent failure of a (b)(4), ecg lead set 3 lead. The customer did not report any patient/user involvement.

 
Search Alerts/Recalls

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Brand NameHEARTSTART MRX 3 WIRE (SNAP) AAMI
Type of DeviceECG LEAD SET
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
wendy chadbourne
3000 minuteman road
andover, MA 01810
MDR Report Key4944831
MDR Text Key17942662
Report Number1218950-2015-03946
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User facility,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/01/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/28/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM3526A
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/01/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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