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

Model Number CR2

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 04/09/2024

Event Type  malfunction  

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.The customer will receive a replacement device.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.

Event Description

The customer contacted stryker to report that their device delivered autonomously shock when users were performing cpr.In this state, wrong defibrillation therapy may be delivered.There were no adverse consequences to the patient as a result of the reported event.

Event Description

The customer contacted stryker to report that their device automatically delivered shock to the patient even though the patient was awake with stabile vital signs.There were no adverse consequences to the patient as a result of the reported event.

Manufacturer Narrative

Executive summary of initial mdr indicates: the customer contacted stryker to report that their device delivered autonomously shock when users were performing cpr.In this state, wrong defibrillation therapy may be delivered.There were no adverse consequences to the patient as a result of the reported event.Executive summary of initial mdr should indicate: the customer contacted stryker to report that their device automatically delivered shock to the patient even though the patient was awake with stabile vital signs.There were no adverse consequences to the patient as a result of the reported event.

Manufacturer Narrative

The product assessment center (pac) technician evaluated the customer's device and was not able to verify the reported issue.A root cause of the reported issue could not be determined.The device was archived by stryker.Section a4 weight units of initial mdr indicates: kilogram(s).Section a4 weight units of initial mdr should indicate: pounds.

Event Description

The customer contacted stryker to report that their device automatically delivered shock to the patient even though the patient was awake with stabile vital signs.There were no adverse consequences to the patient as a result of the reported event.

• Brand Name: LIFEPAK(R) 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: 19218279
• MDR Text Key: 341596624
• Report Number: 0003015876-2024-01385
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873824115
• UDI-Public: 00883873824115
• 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,Followup
• Report Date: 05/23/2024

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: 99512-001263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/16/2024; 05/21/2024
• Supplement Dates FDA Received: 05/16/2024; 05/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2021
• 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
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White