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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA, LLC PHILIPS PAGEWRITER TC70 ELECTROCARDIOGRAPH

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PHILIPS NORTH AMERICA, LLC PHILIPS PAGEWRITER TC70 ELECTROCARDIOGRAPH Back to Search Results
Model Number TC70
Device Problems Fire (1245); Smoking (1585); Explosion (4006)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/11/2020
Event Type  Malfunction  
Event Description

In the early morning, emergency department staff smelled fire smoke, investigating it lead them to an ecg device plugged in one of the ed bays. After few minutes, the device started to spark and in no time it caught on fire. Staff moved the device to outside the building, where flames were all over the device. Using a fire extinguisher, the staff extinguished the fire. Yet, the unit bursts in flames again, extinguished again, and then fire starts again. Staff moved the unit further away from the building, and called fire department. After few minutes, the unit made a mini explosion, shooting the batteries off about 40 feet away in what seemed to be a ball of fire. Eventually, staff were able to extinguish the flames, keeping the unit outside. Biomed did the investigation on the unit, and appeared the batteries are the reason of the fire and the explosion. Batteries are the original philips batteries that came with the unit. Biomed removed all batteries from all philips ecg units in the health system. Philips service manual doesn't include any requirement to replace the batteries at any frequency. Attached to this report the battery maintenance and performance verification instructions from the service manual. Manufacturer response for ecg, philips (per site reporter). They will escalate to their teams to check.

 
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Brand NamePHILIPS PAGEWRITER TC70
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
PHILIPS NORTH AMERICA, LLC
3000 minuteman rd
andover MA 01810
MDR Report Key10400935
MDR Text Key202704809
Report Number10400935
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 BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 08/11/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/13/2020
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberTC70
Device LOT Number1446-0156
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/11/2020
Device Age5 yr
Event Location Hospital
Date Report TO Manufacturer08/13/2020
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? No
Type of Device Usage

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