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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 Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Serial number unknown.A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported a failure of the ecg trunk cable.Patient involvement is unknown.There was no reported patient incident/injury.
 
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
Type of Device
ECG TRUNK CABLE
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
hewlett-packard str.2
boeblingen 71034
GM  71034
MDR Report Key9633686
MDR Text Key181393827
Report Number9610816-2020-00035
Device Sequence Number1
Product Code DSA
UDI-Device Identifier00884838010925
UDI-Public(01)00884838010925
Combination Product (y/n)N
PMA/PMN Number
K020531
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 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
Device Operator 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 Manufacturer Received 01/23/2020
Initial Date FDA Received01/27/2020
Supplement Dates Manufacturer Received01/23/2020
Supplement Dates FDA Received06/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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