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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS 5 LEAD ECG TRUNK CABLE, AAMI/IEC 2.7M
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PHILIPS MEDICAL SYSTEMS 5 LEAD ECG TRUNK CABLE, AAMI/IEC 2.7M Back to Search Results
Model Number M1668A
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Serial number unknown.Phone not provided.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.
 
Event or Problem Description
The customer reported a failure of the ecg trunk cable.There was no patient involved.
 
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
5 LEAD ECG TRUNK CABLE, AAMI/IEC 2.7M
Common Device Name
ECG TRUNK CABLE
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
boeblingen 71034
GM  71034
MDR Report Key9642654
Report Number9610816-2020-00036
Device Sequence Number2204641
Product Code DSA
UDI-Device Identifier00884838010963
UDI-Public(01)00884838010963
Combination Product (Y/N)N
Initial Reporter StateNY
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 Other
Type of Report Initial,Followup
Report Date (Section B) 01/24/2020
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 NumberM1668A
Device Catalogue Number989803145061
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 01/24/2020
Supplement Date Received by Manufacturer01/24/2020
Initial Report FDA Received Date01/29/2020
Supplement Report FDA Received Date04/08/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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