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

Model Number 15

Device Problem Loss of Power (1475)

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

Event Date 02/12/2021

Event Type  malfunction  

Manufacturer Narrative

Physio control evaluated the customers device and verified the reported issue.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.Physio-control contacted the customer to request additional information on the patient.The customer informed physio-control that no further patient information is available. .

Event Description

A customer contacted physio control to report that their device had experienced an unexpected loss of power.The patient associated with the reported event did not survive, however they do not believe that the device use contributed to the patient's outcome.

Event Description

A customer contacted physio control to report that their device had experienced an unexpected loss of power.The patient associated with the reported event did not survive, however they do not believe that the device use contributed to the patient's outcome.

Manufacturer Narrative

It was determined the cause of the issue was a depleted battery (accessory).Physio control reviewed the electronic records and found that the state of charge for battery 2 was 5%.During the shutdown battery 2 was low and switched to replace status.After performing unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• 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: 11485972
• MDR Text Key: 240377797
• Report Number: 0003015876-2021-00563
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• 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: 99577-001765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1