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 Patient Involvement (2645)

Event Date 10/22/2014

Event Type  malfunction  

Event Description

The customer contacted physio-control to report that their device intermittently had a white display.A white display is indicative of a device lockup condition that may prevent, or delay, defibrillation therapy if necessary.There was no patient use associated with the reported event.

Manufacturer Narrative

The customer, a biomedical engineer, verified the reported issue.Physio-control provided the customer with technical assistance and recommended that the device be returned to physio for repair.It was later confirmed by the biomedical engineer that due to the potential cost of repairing the device, that they have declined repair.The device has been permanently removed from service.The device has not been returned to physio-control for evaluation.The cause of the reported issue could not be determined.

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.

• 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: 4251963
• MDR Text Key: 5012150
• Report Number: 3015876-2014-01362
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/22/2014

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: 20
• Device Catalogue Number: 3202487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 9 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 11/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2005
• 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