MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 15

Device Problem Unexpected Shutdown (4019)

Patient Problems Tachycardia (2095); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2023

Event Type  malfunction  

Manufacturer Narrative

Due to character limitations section e1, initial reporter phone, was left blank.The initial reporter¿s phone number is (b)(6).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 unexpectedly lost power multiple times during intervention on a patient.In this state, the device may not be able to provide defibrillation therapy, if it were needed.This issue is patient related; however there was no adverse patient outcome reported.

Event Description

The customer contacted stryker to report that their device unexpectedly lost power multiple times during intervention on a patient.In this state, the device may not be able to provide defibrillation therapy, if it were needed.This issue is patient related; however there was no adverse patient outcome reported.

Manufacturer Narrative

A stryker service representative performed an initial evaluation of the customer¿s device and was able to verify but not to duplicate the reported issue.A customer quality engineer reviewed electronic device records and verify that the device lost power three times.The batteries that were used during the event were past its recommended use-by date.However, they were not returned for evaluation and therefore the root cause could not be determined.The battery pins were replaced as a precaution.The device passed functional and performance testing and was returned to the customer.

• Brand Name: LIFEPAK(R) 15 MONITOR/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: 17926245
• MDR Text Key: 325573628
• Report Number: 0003015876-2023-01883
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

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: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-000795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 01/05/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2013
• 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: 67 YR
• Patient Sex: Female