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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
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Serial number unknown.A follow-up report will be submitted once the investigation is complete.
 
Event or Problem Description
The customer reported a failure of the ecg trunk cable.Patient involvement is unknown.There was no reported patient incident/injury.
 
Additional Manufacturer Narrative
Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
10 LEAD ECG TRUNK AAMI/IEC 2M
Common Device Name
ECG TRUNK CABLE
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
boeblingen 71034
GM  71034
MDR Report Key9633686
Report Number9610816-2020-00035
Device Sequence Number688260
Product Code DSA
UDI-Device Identifier00884838010925
UDI-Public(01)00884838010925
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K020531
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date (Section B) 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberM1663A
Device Catalogue Number989803144791
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2020
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 01/23/2020
Supplement Date Received by Manufacturer01/23/2020
Initial Report FDA Received Date01/27/2020
Supplement Report FDA Received Date06/01/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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