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

Model Number	CRPLUS
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/09/2018
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 displayed all three icons (charge-pak, attention, and service wrench) and would no longer power on.The customer also advised that their device periodically makes a ¿rattling noise¿.The customer advised that the charge-pak installed in their device had a lot code of 1616 and expiration date of (b)(4) 2019.There was no patient use associated with this event.
Additional Manufacturer Narrative
Physio-control evaluated the customer¿s device and verified the reported issue.Physio determined that the cause of the reported issue was due to the digital pcb assembly.However, further component cause could not be determined.The customer was provided with a replacement device.
Event or Problem Description
The customer contacted physio-control to report that their device displayed all three icons (charge-pak, attention, and service wrench) and would no longer power on.The customer also advised that their device periodically makes a ¿rattling noise¿.The customer advised that the charge-pak installed in their device had a lot code of 1616 and expiration date of 2019/05/09.There was no patient use associated with this event.
Additional Manufacturer Narrative
Section d4 of the initial medwatch report indicates: device identifier (di) number ¿ blank.Section d4 of the initial medwatch report should indicate: device identifier (di) number ¿ (b)(4).
Event or Problem Description
The customer contacted physio-control to report that their device displayed all three icons (charge-pak, attention, and service wrench) and would no longer power on.The customer also advised that their device periodically makes a ¿rattling noise¿.The customer advised that the charge-pak installed in their device had a lot code of 1616 and expiration date of (b)(6) 2019.There was no patient use associated with this event.

• 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: 7379253
• Report Number: 0003015876-2018-00513
• Device Sequence Number: 1373176
• Product Code: MKJ
• UDI-Device Identifier: 00885074440323
• UDI-Public: 00885074440323
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2020

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?: Yes
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 04/26/2018; 01/16/2020
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 05/02/2018; 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1