MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LUCAS 2 BATTERY CHARGER; EXTERNAL DEVICE BATTERY CHARGER

Catalog Number 11576-000049

Device Problems Fire (1245); Appropriate Term/Code Not Available (3191)

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

Event Date 05/28/2021

Event Type  malfunction  

Manufacturer Narrative

Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

A customer contacted physio-control to report that their battery vented while it was in the battery charger.There was no patient use associated with the reported event.

Manufacturer Narrative

The battery and charger were returned to stryker and were sent to intertek and mascot for evaluation.Through visual evaluation it was confirmed that the battery had swollen up and likely caught fire as evidenced by the excessive burnt battery/charger material.Battery analysis: a 3d scan was performed and it was observed that a hole was pierced through the battery cell at the front of the battery and continuing through the different layers of the cell.The hole appears to have been caused by a pointed object when the battery was either already heated or prior to the event.The customer was contacted regarding the hole and they had informed that the battery and charger were moved into a container using forceps, the puncture could have been caused then, however it could not be confirmed.Due to the state of the battery pack being severely burnt, no further analysis of the cells could be performed.Therefore, it was confirmed that the battery failed, however after evaluation further root cause could not be determined.Charger analysis: the charger was evaluated and was unable to duplicate or verify the reported issue.The voltage output was normal even after the event.During inspection it was observed that the constant current function was not functional, however it was determined that even if the constant current function had been inoperable prior to the reported event, it is unlikely to have caused an event such as this.There is no indication that the charger was the root cause of the reported issue.

Event Description

A customer contacted physio-control to report that their battery vented while it was in the battery charger.There was no patient use associated with the reported event.

• Brand Name: LUCAS 2 BATTERY CHARGER
• Type of Device: EXTERNAL DEVICE BATTERY CHARGER
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SW SE-223 70
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 12325580
• MDR Text Key: 266702499
• Report Number: 3005445717-2021-00013
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2021,07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11576-000049
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/31/2021
• Device Age: 0 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2021
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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