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

Model Number 20

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

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

Event Date 09/27/2014

Event Type  malfunction  

Event Description

The customer contacted physio-control to report that their device powered off twice when they tried to treat a patient.The device had been connected to a patient in cardiac arrest and it powered itself off.The device was restarted but powered off again.A backup device was then successfully used to provide defibrillation therapy to the patient.There was patient use associated with the reported event however, there was no adverse outcome for the patient reported.No patient details were provided.

Manufacturer Narrative

(b)(4): physio-control evaluated the device but could not verify the reported failure.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 further evaluated the device but could not verify the reported failure.It was observed that an unrelated event code had been logged into the device's memory and that the main keypad was loose.The customer declined repair of the device and requested the device to be returned to them without being repaired.A cause of the reported failure could therefore 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: 4225906
• MDR Text Key: 4970521
• Report Number: 3015876-2014-01309
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/08/2014

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 9 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 11/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2005
• 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