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

Model Number CR PLUS

Device Problems Failure to Charge (1085); Failure to Deliver Energy (1211)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

Physio-control evaluated the customers device and verified the reported issue and isolated the issue to the digital pcba.The customer received a replacement device.

Event Description

The customer contacted physio-control to report a non-critical report, that their device "red "caution" symbol on display." however, it was then determined, "unit will not charge or release energy." in this state the device would not be able to deliver defibrillation therapy if needed.There was no report of patient involvement associated to this event.

Event Description

The customer contacted physio-control to report a non-critical report, that their device "red "caution" symbol on display." however, it was then determined, "unit will not charge or release energy." in this state the device would not be able to deliver defibrillation therapy if needed.There was no report of patient involvement associated to this event.

Manufacturer Narrative

The root cause of the reported failure was determined to be depleted hybrid layer capacitor batteries on the analog pcb.The device could not be repaired.The customer was provided with a warranty device.

• Brand Name: LIFEPAK CR® PLUS DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 12478799
• MDR Text Key: 271652323
• Report Number: 0003015876-2021-01776
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873820551
• UDI-Public: 00883873820551
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: CR PLUS
• Device Catalogue Number: 99403-000156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 12/10/2021
• Supplement Dates FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1