MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	1000
Medical Device Problem Code	Failure to Run on Battery (1466)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer's battery and verified the reported issue.Physio determined that cause of the reported issue was due to a failure of one of the battery cells.This caused the device to not be able to remain powered on and the device cannot charge and shock.The customer received a replacement battery.
Event or Problem Description
The customer contacted physio-control to report that their device had displayed a premature low-battery indicator.There was no patient use associated with the reported event.Upon further investigation, physio-control found that one cell in the battery has failed and the battery cannot perform correctly.As a result, the device cannot remain powered on to charge and shock.

• Brand Name: LIFEPAK® 1000 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: 7679753
• Report Number: 0003015876-2018-01083
• Device Sequence Number: 1369940
• Product Code: MKJ
• UDI-Device Identifier: 00883873919477
• UDI-Public: 00883873919477
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2018

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: Health Professional
• Device Model Number: 1000
• Device Catalogue Number: 11141-000156
• Device Lot Number: 1728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1