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 Analyze Signal (1539)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio-control determined that the cause of the reported issue was process residue on capacitor c156, leg 3, of the analog pcb assembly that keeps the ecg preamp from recognizing a shockable rhythm.The customer was provided with a replacement device.
Event or Problem Description
The customer contacted physio-control to report that their device displayed a service indicator.There was no patient use associated with the reported event.Upon evaluation of the customer¿s device, physio-control found that the it did not recognize a shockable rhythm.As a result, defibrillation would not be possible if it were necessary.
Event or Problem Description
The customer contacted physio-control to report that their device displayed a service indicator.There was no patient use associated with the reported event.Upon evaluation of the customer¿s device, physio-control found that the it did not recognize a shockable rhythm.As a result, defibrillation would not be possible if it were necessary.
Additional Manufacturer Narrative
Section d4 of the initial medwatch report indicates: gtin/device identifier (di) number ¿ blank.Section d4 of the initial medwatch report should indicate: gtin/device identifier (di) number ¿ (b)(4).Section d4 of the initial medwatch report indicates: model # ¿ 15.Section d4 of the initial medwatch report should indicate: model # ¿ crplus.

• 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: 7444448
• Report Number: 0003015876-2018-00621
• Device Sequence Number: 1768531
• Product Code: MKJ
• UDI-Device Identifier: 00883873894262
• UDI-Public: 00883873894262
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K033275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

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: 99403-000157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1