MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SS BAT LI-ION (9 CELL)

Model Number 989803194541

Device Problem Fire (1245)

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

Event Date 04/04/2022

Event Type  malfunction  

Manufacturer Narrative

A philips field service engineer (fse) reported that eight philips batteries were damaged in a basement fire.These eight batteries were part of a set of ten, two were returned to shanghai for investigation, and eight were left in fse¿s basement.There was no reported patient incident or injury.Philips was able to obtain the fire investigator report which stated that "there was nothing seen among the debris that revealed a competent ignition source.The possibility of a problem with any of the rechargeable batteries is something that i cannot eliminate at this time." two batteries not in the fire were evaluated, both were working as designed an no problem could be found.The fire was reported to insurance company, and the cause of the fire is not clear in their report.Philips batteries were not being charged at the time of the fire, and there are many other batteries in the basement from fse¿s information.There was no evidence that the philips battery was the cause of the fire.

Event Description

A philips field service engineer (fse) reported that eight philips batteries were damaged in a basement fire.The device was not in use on a patient at the time of event, there was no adverse event reported.

Manufacturer Narrative

The lot number was corrected from unknown to 4697.

• Brand Name: SS BAT LI-ION (9 CELL)
• Type of Device: SS BAT LI-ION (9 CELL)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15129902
• MDR Text Key: 296870373
• Report Number: 1218950-2022-00651
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• 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: Other
• Device Model Number: 989803194541
• Device Catalogue Number: 989803194541
• Device Lot Number: 4697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 07/29/2022
• Supplement Dates FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2021
• 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