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	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted stryker to report that their device would not provide audio voice prompts.Without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient which could delay therapy.There was no patient involvement in this event.
Additional Manufacturer Narrative
Stryker continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.H3 other text : not returned to manufacturer.
Additional Manufacturer Narrative
The device was not returned to stryker for evaluation.The customer confirmed that the device presented a fault condition due to old age.As such, the device could not be repaired and the customer was advised to replace the device.The reported issue was unable to be verified and unable to be duplicated.A cause of the reported issue could not be determined.
Event or Problem Description
A customer contacted stryker to report that their device would not provide audio voice prompts.Without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient which could delay therapy.There was no patient involvement in this event.

• 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
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16856410
• Report Number: 0003015876-2023-00788
• Device Sequence Number: 7637411
• Product Code: MKJ
• UDI-Device Identifier: 00883873820254
• UDI-Public: 00883873820254
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K033275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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: 99403-000004
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 07/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2006
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown