MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 15 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 15

Device Problem Inappropriate or Unexpected Reset (2959)

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

Event Date 01/30/2021

Event Type  malfunction  

Manufacturer Narrative

Physio-control physically evaluated the device and was unable to duplicate the issue.Physio performed an initial evaluation of the device electronic download data and verified the reported issue.The battery pins and one battery were replaced.The device passed functional and performance testing and was returned to the customer.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

Physio-control received a report from a customer that the device turned off multiple times while printing.In this state the device may be inoperable and defibrillation therapy would not be available if needed.There was no report of any patient involvement associated with the event.

Event Description

Physio-control received a report from a customer that the device turned off multiple times while printing.In this state the device may be inoperable and defibrillation therapy would not be available if needed.There was no report of any patient involvement associated with the event.

Manufacturer Narrative

The root cause of this issue is old batteries during a high current function and worn battery pins.After physio replaced the batteries and battery pins, and the device passed all functional and performance tests.The customer received replacement batteries, and the device was returned to the customer for use.

• Brand Name: LIFEPAK 15 DEFIBRILLATOR/MONITOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 11391267
• MDR Text Key: 234037679
• Report Number: 0003015876-2021-00486
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873911631
• UDI-Public: 00883873911631
• Combination Product (y/n): N
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

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: 15
• Device Catalogue Number: 99577-001256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1