MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 1000

Device Problem Failure to Sense (1559)

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

Event Date 07/19/2023

Event Type  Death  

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.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 Description

The customer contacted stryker to report that their device failed to recognize defibrillation pads during intervention on a patient.In this state, the device may not be able to provide defibrillation therapy, if it were needed.The patient associated with the reported event did not survive.The health care provider was not able to confirm if the device use contributed to the patient outcome.

Manufacturer Narrative

It was reported that lp1000 had a "connect cable" or "connect electrodes" message when pads were already applied.The device was sent to a technician for evaluation in (b)(4) (see comm log).The reported issue was unable to verified or duplicated.The unit performed normally during troubleshooting and root cause could not be determined.The technician recommended that the device not be put back into service due to its age (manufacturing date of october 22, 2014).The customer accepted that recommendation and the device was returned without repair.

Event Description

The customer contacted stryker to report that their device failed to recognize defibrillation pads during intervention on a patient.In this state, the device may not be able to provide defibrillation therapy, if it were needed.The patient associated with the reported event did not survive.The health care provider was not able to confirm if the device use contributed to the patient outcome.

• Brand Name: LIFEPAK® 1000 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 17641822
• MDR Text Key: 322168401
• Report Number: 0003015876-2023-01542
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K122600
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1000
• Device Catalogue Number: 99425-000195
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2014
• 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 Outcome(s): Death
• Patient Age: 30 DA
• Patient Sex: Prefer Not To Disclose