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

Model Number CR2

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

The customer received a replacement device.Stryker continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer contacted stryker to report that their device did not provide any voice prompts when the device was powered on.Without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient.There was no patient use associated with the reported event.

Manufacturer Narrative

Stryker evaluated the customer's device verified the reported issue and determined it was caused by a depleted battery.A cause for the depleted battery could not be determined.

Event Description

The customer contacted stryker to report that their device did not provide any voice prompts when the device was powered on.Without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient.There was no patient use associated with the reported event.

• 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
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18947795
• MDR Text Key: 338237810
• Report Number: 0003015876-2024-00588
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873824139
• UDI-Public: 00883873824139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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: 99512-001261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2022
• 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