MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR2 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number CR2

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.

Event Description

The customer contacted physio-control to report that their device did not provide any voice prompts while testing.Without voice prompts, a lay user would not receive the audible instructions on how to properly use the device to deliver defibrillation therapy to a patient.There was no report of patient use associated with the reported event.

Event Description

The customer contacted physio-control to report that their device did not provide any voice prompts while testing.Without voice prompts, a lay user would not receive the audible instructions on how to properly use the device to deliver defibrillation therapy to a patient.There was no report of patient use associated with the reported event.

Manufacturer Narrative

Physio-control evaluated the customer's device and was unable to duplicate the reported issue.The cause of the reported issue could not be determined.The device was archived by physio-control and the customer received a replacement device.

• Brand Name: LIFEPAK CR2 DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 10233498
• MDR Text Key: 198103605
• Report Number: 0003015876-2020-00836
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873824078
• UDI-Public: 00883873824078
• Combination Product (y/n): N
• PMA/PMN Number: P170018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: CR2
• Device Catalogue Number: 99512-001267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 07/24/2020
• Supplement Dates FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1