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

Model Number	1000
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 device had depleted multiple batteries rapidly despite no usage.As a result, the power source (battery) could be prematurely depleted which may delay, or prevent, defibrillation if it were necessary.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
The customer later advised physio-control that they had provided the wrong device serial number when they reported the device issue.As a result, the following information has been updated: serial number, has been updated to indicate: (b)(4).Device di number, has been updated to indicate: (b)(4).Manufacturing date, has been updated to indicate: 07/07/2017.Physio-control evaluated the customer's device but was unable to duplicate the reported issue.Using a test battery, physio-control confirmed that the device would power on, charge and shock during testing.The device was also opened and a visual examination was performed with no discrepancies observed.Physio-control downloaded the device's self-test log for review but did not observe any indication (or history) that batteries were depleting rapidly.Additionally, the downloaded self-test log shows that a 2017 battery had been used in the device until april 10th, 2018, and that the remaining capacity would have shown four bars on the battery indicator.On april 10th, 2018, the battery was changed and a 2009 battery was placed in the device.If a battery is purchased, but not used immediately and placed in a device at a later date, an algorithm in the device will use the battery's manufacturing date to adjust the amount of charge displayed based on the battery's age.It is likely that the 2009 battery used by the customer had been stored previously and that the customer expected it to be fully charged.Instead, the device accounted for the age of the battery when calculating the remaining charge and would have displayed only two bars.This may have appeared as rapid battery depletion to the customer, but is normal device operation.The evidence in the test log shows that no device malfunction occurred and that battery depletion occurred as expected.The customer was provided with a replacement device.
Event or Problem Description
The customer contacted physio-control to report that their device had depleted multiple batteries rapidly despite no usage.As a result, the power source (battery) could be prematurely depleted which may delay, or prevent, defibrillation if it were necessary.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 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: 7495281
• Report Number: 0003015876-2018-00729
• Device Sequence Number: 1417375
• Product Code: MKJ
• UDI-Device Identifier: 00885074698878
• UDI-Public: 00885074698878
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 07/10/2018

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: 99425-000023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1