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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CBL 3 LEAD ECG PATIENT TRUNK, AAMI ECG TRUNK CABLE

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PHILIPS MEDICAL SYSTEMS CBL 3 LEAD ECG PATIENT TRUNK, AAMI ECG TRUNK CABLE Back to Search Results
Model Number M1500A
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Event Description

The customer reported failure of the m1500a ecg trunk cable. No further information was provided. The customer did not report any patient/user involvement.

 
Manufacturer Narrative

Pr#: (b)(4). A follow up report will be submitted once the investigation is complete.

 
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Brand NameCBL 3 LEAD ECG PATIENT TRUNK, AAMI
Type of DeviceECG TRUNK CABLE
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover MA 01810
Manufacturer Contact
wendy chadbourne
3000 minuteman rd.
andover, MA 01810
9788597804
MDR Report Key4743364
MDR Text Key5771727
Report Number1218950-2015-02281
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK020531
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User facility
Reporter Occupation
Type of Report Initial
Report Date 04/02/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/28/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM1500A
Was Device Available For Evaluation? Yes
Date Manufacturer Received04/02/2015
Was Device Evaluated By Manufacturer? No
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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