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 06/26/2014

Event Type  malfunction  

Event Description

The customer contacted physio-control to report that when monitoring a patient the device displayed a white screen.This is an indication that the device would be inoperable and defibrillation therapy would not be available if needed.This issue is patient related; however there was no adverse patient outcome.

Manufacturer Narrative

(b)(4): physio-control evaluated the customer¿s device but was unable to verify or duplicate the reported issue.After physio-control observes proper device operation through functional and performance testing, the device will be returned to the customer for use.The cause of the reported issue could not be determined.

Manufacturer Narrative

As a precaution, physio-control replaced both the system controller (sc) and user interface (ui) pcb assemblies and after observing proper device operation through functional and performance testing the unit was returned to the customer for use.Physio further examined the ui pcb assembly and observed that an integrated circuit (ic) chip, designator u8, would cause an intermittent blank screen; however, the unit was otherwise operational and would still deliver defibrillation therapy when prompted.There was no evidence of a device lock up observed.The removed sc pcb assembly was an ancillary part and there was no failure of the assembly.The cause of the original issue, device lock up, 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: 3953632
• MDR Text Key: 4609869
• Report Number: 3015876-2014-00842
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/26/2014

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: 07/10/2014
• Is the Reporter a Health Professional?: Yes
• Device Age: 8 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/27/2014
• Initial Date FDA Received: 07/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2006
• 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