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 08/02/2014

Event Type  malfunction  

Event Description

It was reported to physio-control that the customer's device during cardioversion on a patient automatically started the self-test again several times.The device kept rebooting and could therefore not deliver therapy.A back-up device was used to treat the patient.There was patient use associated with the reported event; however there was no adverse patient outcome reported.

Manufacturer Narrative

(b)(4).Physio-control evaluated the device and verified 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 observed that the device had logged multiple event codes which were indicative of a failure of the system pcb assembly and/or user interface pcb assembly.Physio-control advised replacement of the system pcb and user interface pcb assemblies.The customer declined repair of the device and requested to have the device returned without being repaired.A conclusive cause of the reported failure 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: 4050308
• MDR Text Key: 4864648
• Report Number: 3015876-2014-01022
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2014

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: 3202488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 10 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/12/2014
• Initial Date FDA Received: 09/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2002
• 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: 72 YR
• Patient Weight: 86