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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 Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

The customer reported leads in the package do not match the label on the package. There was no reported patient involvement.

 
Event Description

The customer reported they received the wrong part (b)(4), ecg lead set). There was no reported patient incident/injury. The issue was discovered after the product was received at the customer site, prior to being put into use.

 
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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 Key5685303
MDR Text Key46099369
Report Number1218950-2016-03182
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
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/04/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/27/2016
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? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/04/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/18/2007
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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