MAUDE Adverse Event Report: PHYSIO-CONTROL, INC LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number 20

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2014

Event Type  malfunction  

Event Description

The customer, director of clinical technologies, contacted physio-control to report that during a recent patient event their device powered off by itself.The patient, a (b)(6) year-old female, had been diagnosed as bradycardic (heart rate was approximately 20 bpm) and had been connected to the physio device to receive external pacing therapy.During the event, the patient was also connected to an external bedside monitor which alarmed to notify the hospital staff that the patient was asystolic.Upon entering the room, the hospital staff observed that the physio device had stopped pacing the patient, completed a self-test, and then powered off by itself.A backup device was obtained and used to continue pacing the patient.The patient survived the event.There were no adverse effects to the patient that were reported as a result of the reported issue.Upon evaluation of the device, the facility biomedical engineer observed that it would not complete the boot up cycle and appeared to be locked up.

Manufacturer Narrative

(b)(4).Physio-control 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.

Manufacturer Narrative

Physio-control evaluated the device and was unable to duplicate or verify the reported device issue.It was observed that the device had logged some event codes which did not appear to be related to the reported power/lock up issue.Physio then recommended repair for the non critical event codes but the customer decided to decline repairs due to costs.The event codes were cleared and proper device operation was observed through functional and performance testing.The device was then returned to the customer for use.The cause of the reported power/lock up issue could not be determined.

• Brand Name: LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
• 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: 4182354
• MDR Text Key: 5093144
• Report Number: 3015876-2014-01232
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20
• Device Catalogue Number: 3202487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2015
• Is the Reporter a Health Professional?: No
• Device Age: 12 YR
• Event Location: Hospital
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2002
• 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 Age: 74 YR