MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 15

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio-control then replaced the device's system pcb assembly and completed other, unrelated, repairs.After observing proper device operation through functional and performance testing the unit was returned to the customer for use.

Event Description

The customer contacted physio-control to report that their device would not complete the boot-up process in order to power on.As a result, defibrillation would not have been possible if it were necessary.There was no patient use associated with the reported issue.

Manufacturer Narrative

Physio-control further evaluated the removed system pcb assembly and determined that the cause of the reported issue was that the single board computer (sbc) located on the assembly was inoperative.

Event Description

The customer contacted physio-control to report that their device would not complete the boot-up process in order to power on.As a result, defibrillation would not have been possible if it were necessary.There was no patient use associated with the reported issue.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• 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: meg marseglia ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 7621354
• MDR Text Key: 111850165
• Report Number: 0003015876-2018-00971
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873988039
• UDI-Public: 00883873988039
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

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: 15
• Device Catalogue Number: 99577-000045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 09/10/2018
• Supplement Dates FDA Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2011
• 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