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

Model Number 9P

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2014

Event Type  malfunction  

Event Description

The customer contacted physio-control to report that their device would lockup shortly after being powered on.In this condition the device would not be able to provide defibrillation, if necessary.There was no patient use associated with the reported event.

Manufacturer Narrative

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

• Brand Name: LIFEPAK(R) 9P DEFIBRILLATOR/MONITOR/PACEMAKER
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 970
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 970
• Manufacturer Contact: jason march ; 4258674000
• MDR Report Key: 4310234
• MDR Text Key: 21496896
• Report Number: 3015876-2014-01474
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/19/2014

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: 805460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 20 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 12/09/2014
• Date Device Manufactured: 02/01/1994
• 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