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

Model Number CRPLUS

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Patient Involvement (2645)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio determined that the cause of the reported issue was due to a solder defect on post 1 of integrated circuit, designator u1, on the analog pcb assembly.The customer received a replacement device.

Event Description

The customer contacted physio-control to report a non-critical issue with their device.There was no report of patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that the device delivered a monophasic shock at a reduced energy level.As a result, the wrong defibrillation therapy may be delivered to a patient, if it was needed.

• 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: 8925592
• MDR Text Key: 190122068
• Report Number: 0003015876-2019-01406
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873820568
• UDI-Public: 00883873820568
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K033275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 07/26/2019
• Date Manufacturer Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2017
• 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