MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 20

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 12/31/2021

Event Type  malfunction  

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Stryker will not request any patient identifying information to be in accordance with regulation (eu) (b)(4) of the (b)(6) parliament and of the council.Stryker evaluated the customer's device and verified the reported issue.It was observed that the pin in the therapy socket was broken.After replacing the therapy connector and performing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.

Event Description

A customer contacted stryker to report that their device gave 'abnormal energy' messages during patient use.As a result, defibrillation therapy would not be available, if needed.The patient associated with the reported event did not survive.The customer confirmed that the device use did not contribute to the patient outcome.

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Stryker will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.Stryker evaluated the customer's device and verified the reported issue.It was observed that the pin in the therapy socket was broken.After replacing the therapy connector and performing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.

Event Description

A customer contacted stryker to report that their device gave 'abnormal energy' messages during patient use.As a result, defibrillation therapy would not be available, if needed.The patient associated with the reported event did not survive.The customer confirmed that the device use did not contribute to the patient outcome.

Manufacturer Narrative

Additional mfg narrative of the initial medwatch report indicates stryker evaluated the customer's device and verified the reported issue.It was observed that the pin in the therapy socket was broken.After replacing the therapy connector and performing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.Section h10 and/or h11, additional mfg narrative of the initial medwatch report should indicate a third-party service agent evaluated the customer's device and verified the reported issue.It was observed that the pin in the therapy socket was broken.After replacing the therapy connector and performing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.

Event Description

A customer contacted stryker to report that their device gave 'abnormal energy' messages during patient use.As a result, defibrillation therapy would not be available, if needed.The patient associated with the reported event did not survive.The customer confirmed that the device use did not contribute to the patient outcome.

Manufacturer Narrative

The removed therapy connector was further evaluated at stryker product analysis center (pac).It was observed that pin 6 of the therapy connector was blocked by a stuck piece that appears to be a broken off pin.The cause of the reported issue was determined to be due to a fractured pin in the therapy connector.

Event Description

A customer contacted stryker to report that their device gave 'abnormal energy' messages during patient use.As a result, defibrillation therapy would not be available, if needed.The patient associated with the reported event did not survive.The customer confirmed that the device use did not contribute to the patient outcome.

• Brand Name: LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
• 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 13366577
• MDR Text Key: 285253405
• Report Number: 0003015876-2022-00104
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20
• Device Catalogue Number: 99402-000017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2002
• 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