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

Model Number 9P

Device Problem Failure To Run On AC/DC (1001)

Patient Problem No Patient Involvement (2645)

Event Date 03/09/2015

Event Type  malfunction  

Event Description

The customer contacted physio-control to report that their device would not power on.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.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: 4650417
• MDR Text Key: 19404712
• Report Number: 3015876-2015-00385
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K881153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/09/2015

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: 15 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/09/2015
• Initial Date FDA Received: 04/01/2015
• Date Device Manufactured: 11/18/1999
• 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