MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number 99400-000437

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control provided the customer with the part number for the therapy connector in the device and a defibrillation therapy cable assembly.Physio-control 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 physio-control to report that a pin from the defibrillation therapy cable assembly had broken off inside the therapy connector assembly of their device.The customer advised that a staff member had pulled on the cable which resulted in the pin breaking off.As a result, defibrillation therapy would not likely be available because another defibrillation therapy cable or hard paddle assembly would not plug in to the device.There was no patient use associated with the reported event.

Manufacturer Narrative

Physio-control has attempted to contact the customer regarding the status of their device but has not been successful.Because physio-control has been unable to reach the customer, it is unknown what the current status of the device is.It is unknown if the customer will be replacing the device or returning it to physio-control for evaluation.The device has not been returned to physio-control.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.

Event Description

The customer contacted physio-control to report that a pin from the defibrillation therapy cable assembly had broken off inside the therapy connector assembly of their device.The customer advised that a staff member had pulled on the cable which resulted in the pin breaking off.As a result, defibrillation therapy would not likely be available because another defibrillation therapy cable or hard paddle assembly would not plug in to the device.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
• 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: meg marseglia ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 7672197
• MDR Text Key: 113503959
• Report Number: 0003015876-2018-01064
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 99400-000437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2001
• 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