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

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.

Event Description

A philips field service engineer (fse) reported that 8 philips batteries were damaged in a basement fire.These 8 batteries were part of a set of 10, 2 were returned to shanghai for investigation, 8 were left in fse¿s basement.There was no patient involvement and not in clinical use.

• 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: 15130600
• MDR Text Key: 296878367
• Report Number: 1218950-2022-00652
• 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

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 Model Number: 989803194541
• Device Catalogue Number: 989803194541
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: No
• 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