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

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.

• Brand Name: PHILIPS PAGEWRITER TC70
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHILIPS NORTH AMERICA, LLC; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 10400935
• MDR Text Key: 202704809
• Report Number: 10400935
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TC70
• Device Lot Number: 1446-0156
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2020
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA