MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 20

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control evaluated the customer's device and was able to duplicate the reported issue.Physio replaced the system controller pcb assembly, which resolved the reported issue.After other unrelated repairs were completed, proper device operation was observed.The device was returned to the customer for use.Physio-control further evaluated the removed system controller pcb assembly and determined the cause of the reported issue was due to integrated circuit, designator u61.The u61 was electrically shorted and caused the device to lock up and not complete the boot-up process.

Event Description

The customer contacted physio-control to report that their device would not complete the boot-up process intermittently.When the device would complete the boot-up process, the screen would start flashing.As a result, defibrillation may not be possible, if it were necessary.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK® 20 DEFIBRILLATOR/MONITOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: megan marseglia ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 7603284
• MDR Text Key: 111152154
• Report Number: 0003015876-2018-00938
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• 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: 99402-000016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2004
• 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