MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK EXPRESS DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE

Model Number	EXPRESS
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
The customer contacted physio-control to report that their aed would verbalize when they open the front lid and it would not stop verbalizing when they close the lid.In this state, the device hlc internal battery could experience premature depletion and if needed, defibrillation (automated, manual or synchronized cardioversion) therapy may not be able to be delivered.There was no report of patient use associated to the reported event.
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and was unable to duplicate or verify the reported issue.No repairs were made.No root cause could be determined.
Event or Problem Description
The customer contacted physio-control to report that their aed would verbalize when they open the front lid and it would not stop verbalizing when they close the lid.In this state, the device hlc internal battery could experience premature depletion and if needed, defibrillation (automated, manual or synchronized cardioversion) therapy may not be able to be delivered.There was no report of patient use associated to the reported event.

• Brand Name: LIFEPAK EXPRESS DEFIBRILLATOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 10557086
• Report Number: 0003015876-2020-01279
• Device Sequence Number: 16936028
• Product Code: MKJ
• UDI-Device Identifier: 00883873823644
• UDI-Public: 00883873823644
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K033275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: EXPRESS
• Device Catalogue Number: 99427-000129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1