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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS ELECTROCARDIOGRAPH

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PHILIPS MEDICAL SYSTEMS PHILIPS ELECTROCARDIOGRAPH Back to Search Results
Model Number 860315
Device Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/29/2020
Event Type  Malfunction  
Event Description

Was attempting to do a stat ecg. Placed stickers on patient, attached leads to stickers as appropriate. The ecg machine did not show valid tracings on the screen. Narrow tracings appeared to flicker and were very unusual. Obtained another ecg machine from main hospital to perform the required ecg.

 
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Brand NamePHILIPS
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key10024276
MDR Text Key189869646
Report Number10024276
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/05/2020
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number860315
Device Catalogue Number860315
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/24/2020
Event Location Hospital
Date Report TO Manufacturer05/05/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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