MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 9P DEFIBRILLATOR/MONITOR/PACEMAKER; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number 9P

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control advised the customer that their device is no longer supported by physio.As a result, service and parts are no longer available.Physio-control recommended that the device be permanently removed from service and that a replacement unit be obtained.The device has not been returned to physio-control for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.

Event Description

The customer, a biomedical engineer, contacted physio-control to report that their device was locked in pacing mode.The biomedical engineer further advised that when he attempted to go into the setup menu, it would only stay in the menu for approximately 2 seconds before reverting back to the home screen where it was locked in pacing mode.Additionally, the device would not power off when the power button was pressed.As a result, defibrillation was not likely possible if it were necessary.There was no patient use associated with the reported event.The biomedical engineer did not provide physio-control with the serial number of the device.Physio-control has reached out to the customer to request the serial number, however, no response has been received.

• Brand Name: LIFEPAK(R) 9P DEFIBRILLATOR/MONITOR/PACEMAKER
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• 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: 8081054
• MDR Text Key: 127872078
• Report Number: 0003015876-2018-01927
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902288
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/16/2018

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: 9P
• Device Catalogue Number: 99413-000034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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