MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC50 CARDIOGRAPH

Model Number 860310

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.(b)(6).

Event Description

The customer reported that while the unit was under charging condition, the battery caught fire and damaged the unit.The device was not in use on a patient at the time of the event fse had inspected the site and kept the unit for further investigation.A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

Visual inspection confirmed that the device was damaged by flames.The battery pack is severely charred and destroyed.The complaint was escalated for technical investigation and the results indicate the tc50 is on software version a.06.03.03, a philips product support engineer (pse) investigated this issue.The device was scanned utilizing a computed tomograhpy (ct) device.The printed circuit board (pcb) was evaluated by the pse.The pse concluded that there was no evidence of high currents on pcb, open chemical fuse, and open tco.The pse evaluated the gas gauge readout logs and determined the battery was thermally stressed and had a higher voltage than safety over voltage.The pse evaluated the device logs and determined the following: high temperature during charging, indicating high internal resistance of cells.High voltage at start of charge, indicating high internal resistance of cells.Abnormal charging currents, possible issue with balancing due to high internal resistance of cells.¿the unit was under charge - connected with power outlet.¿ the pf volatge was 8705mv and current = 0 when the monitor was shut off it was 10560mv, this does not indicate that the monitor was charging.The exact time were not sure, but it¿s between 12:39(log record) ¿ 4(fire put off) pm nov.30th , customer claimed the incident happened around 3 pm.The pf does not include time.The pse concludes that the high internal resistance and the imbalance of the cells indicate an end of life failure, potentially related to electrode degradation and/or lithium plating when the cells are worn and aged.The pse additionally observes from the log file that the device did not have the most recent software version implemented.The pse states that if the update would have been performed, the software would have detected the ageing and wear of the battery pack and indicate to the user that the pack is in a critical state.The device was on the units affected list to receive software upgrade, however at the time of the upgrade the device was not able to be located at the medical facility.Analysis was performed and investigation has been completed.The returned device has been discarded per local procedures.Philips has agreed to provide the customer with a replacement device.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Event Description

Philips received a complaint on the pagewriter tc50 cardiograph indicating that the device battery caught fire damaging the unit.The device was not in clinical usage at the time of the event and was isolated in a charging room.Philips engineering confirmed that there was no report of a death or serious injury, nor was there a report of any adverse impact to any user or patient.

• Brand Name: PAGEWRITER TC50 CARDIOGRAPH
• Type of Device: PAGEWRITER TC50 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16056738
• MDR Text Key: 306214927
• Report Number: 1218950-2022-01072
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K080999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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 Number: 860310
• Device Catalogue Number: 860310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1