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

Model Number	CRPLUS
Medical Device Problem Codes	Failure to Power Up (1476); No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer will be provided with 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 their device had all three icons (charge pak, attention and service wrench) present on its readiness display, and when attempting to power the device on there were no voice prompts.Without voice prompts, a device user would not receive the audible instructions on how to properly use the device on a patient which could delay, or prevent, defibrillation if necessary.There was no patient use associated with the reported event.
Event or Problem Description
The customer contacted physio-control to report that their device had all three icons (charge pak, attention and service wrench) present on its readiness display, and when attempting to power the device on there were no voice prompts.Without voice prompts, a device user would not receive the audible instructions on how to properly use the device on a patient which could delay, or prevent, defibrillation if necessary.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer¿s device and verified the reported issue.Physio observed that the device would not power on when prompted, which is why the customer had originally stated that there were no voice prompts.Physio found that the customer had previously installed the shorting plug onto the device¿s charge pak assembly and then removed it.This action of installing and removing the shorting plug crushed the contacts on the charge pak assembly and upon being placed back into the device, caused its internal hybrid layer capacitor (hlc) batteries to deplete which prevented the device from powering on.The cause of the reported issue was determined to be use error due to the customer installing, then removing, a shorting plug onto the charge pak assembly prior to reinstalling it into the device which resulted in the depletion of the internal hlc batteries.

• Brand Name: LIFEPAK CR(R) 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: 7990582
• Report Number: 0003015876-2018-01748
• Device Sequence Number: 1739227
• Product Code: MKJ
• UDI-Device Identifier: 00885074440323
• UDI-Public: 00885074440323
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K033275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2018

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: Lay User/Patient
• Device Model Number: CRPLUS
• Device Catalogue Number: 99403-000156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1