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

Model Number 15

Device Problem Intermittent Loss of Power (4016)

Patient Problems No Consequences Or Impact To Patient (2199); Asystole (4442)

Event Date 04/05/2020

Event Type  malfunction  

Manufacturer Narrative

Physio control performed an initial evaluation of the customer's device and was not able to duplicate the reported issue.The electronic device data was downloaded.Physio control performed a clinical review of the electronic records and verified the device unexpectedly lost power four times.It was determined that the device use did not contribute to the patient outcome, as each analysis that the device rendered a shock decision, the device delivered an effective defibrillation shock, until the patient deteriorated to a rhythm that was not shockable (asystole).Physio-control contacted the customer to request additional information on the patient; however, no response was received. .

Event Description

A customer contacted physio control to report that their device unexpectedly lost power during a patient event.A patient did not survive the event.

Event Description

A customer contacted physio control to report that their device unexpectedly lost power during a patient event.A patient did not survive the event.

Manufacturer Narrative

Physio downloaded the device's electronic records from the event for review and was able to verify the device powered off 4 times during the reported event.Physio observed that the device was running off a 9 year old battery manufactured in 2011.Per the lifepak® 15 monitor/defibrillator operating instructions, the recommended life for this battery is 2 years.Root cause of this reported issue is likely due to the use of a battery passed its recommended service life.Physio control also recommended that the power pcb assembly has to be replaced as a precautionary measure.However, due to a part obsolescence, the device cannot be repaired and will be replaced.

• 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: 10079185
• MDR Text Key: 191703567
• Report Number: 0003015876-2020-00661
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• 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: 99577-000025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1