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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS 10 LEAD ECG TRUNK AAMI/IEC 2M; ECG TRUNK CABLE
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PHILIPS MEDICAL SYSTEMS 10 LEAD ECG TRUNK AAMI/IEC 2M; ECG TRUNK CABLE Back to Search Results
Model Number M1663A
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
An ecg leads related issue could prevent demand mode pacing or delay therapy/treatment.We are still in the process of assessing if there's a risk to health.This complaint is being reported in order to meet the reporting deadlines.A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer reported the m1663a, ecg trunk cable was damaged.The customer did not report any patient/user involvement.
 
Manufacturer Narrative
 
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Brand Name
10 LEAD ECG TRUNK AAMI/IEC 2M
Type of Device
ECG TRUNK CABLE
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
böeblingen 71034
GM  71034
Manufacturer Contact
wendy chadbourne
hewlett-packard str.2
böeblingen 71034
GM   71034
MDR Report Key5238660
MDR Text Key31998089
Report Number9610816-2015-00278
Device Sequence Number1
Product Code DSA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020531
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM1663A
Device Lot Number4C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/05/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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