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

Model Number	CR2
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer contacted stryker to report that the device failed the language button test.Without appropriate language, a user would not understand the audible instructions on how to use the device properly.This may lead to defibrillation therapy being delayed or unavailable if needed.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
The stryker product assessment center (pac) 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 retained by stryker.Section b5 of the initial medwatch report indicates: the customer contacted stryker to report that the device failed the language button test.Without appropriate language, a user would not understand the audible instructions on how to use the device properly.This may lead to defibrillation therapy being delayed or unavailable if needed.Section b5 of the initial medwatch report should indicate: during routine preventative maintenance testing by stryker, the device failed the language button test.Without appropriate language, a user would not understand the audible instructions on how to use the device properly.This may lead to defibrillation therapy being delayed or unavailable if needed.There was no patient involvement reported with the event.
Event or Problem Description
During routine preventative maintenance testing by stryker, the device failed the language button test.Without appropriate language, a user would not understand the audible instructions on how to use the device properly.This may lead to defibrillation therapy being delayed or unavailable if needed.There was no patient involvement reported with the event.

• Brand Name: LIFEPAK® CR2 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 19759300
• Report Number: 0003015876-2024-02205
• Device Sequence Number: 9144532
• Product Code: MKJ
• UDI-Device Identifier: 00883873824108
• UDI-Public: 00883873824108
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P170018
• 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): 09/02/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: CR2
• Device Catalogue Number: 99512-001264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• 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