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

Model Number	CRPLUS
Medical Device Problem Codes	Failure to Power Up (1476); Power Problem (3010)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer received a replacement device.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 the device was showing two icons (attention and charge-pak).There was no report of patient use associated with the reported event.Upon evaluation of the customer's device, physio observed that the device was showing all three icons (attention, charge-pak and service wrench).With all three icons illuminated, the device may not have sufficient power available to deliver effective defibrillation therapy to a patient, if it was needed.Additionally, the device would not power on when prompted, which would also cause the device to be unable to deliver defibrillation therapy to a patient, if it was needed.
Additional Manufacturer Narrative
Upon evaluation of the customer's device, physio observed that the device was showing all three icons (attention, charge-pak and service wrench).Additionally, the device would not power on when prompted, so the reported event was verified.The device was powered on with an external power supply and did successfully charge and shock.During an internal inspection, it was observed that the integrated component, designator u4 on the digital pcb assembly had process residue that resulted in 124 madc off current that drained the hybrid layer capacitor (hlc) batteries prematurely.Physio determined that the cause of the reported issue was that the device had an excessive amount of on-time which depleted the internal hybrid layer capacitor (hlc) batteries and prevented the device from remaining powered on to charge and shock.The device has been archived by stryker.
Event or Problem Description
The customer contacted physio-control to report that the device was showing two icons (attention and charge-pak).There was no report of patient use associated with the reported event.Upon evaluation of the customer's device, physio observed that the device was showing all three icons (attention, charge-pak and service wrench).With all three icons illuminated, the device may not have sufficient power available to deliver effective defibrillation therapy to a patient, if it was needed.Additionally, the device would not power on when prompted, which would also cause the device to be unable to deliver defibrillation therapy to a patient, if it was needed.

• Brand Name: LIFEPAK CR® PLUS 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: 9154069
• Report Number: 0003015876-2019-01658
• Device Sequence Number: 11515158
• Product Code: MKJ
• UDI-Device Identifier: 00883873823927
• UDI-Public: 00883873823927
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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: CRPLUS
• Device Catalogue Number: 99403-000001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1