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

Model Number 20

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Patient Involvement (2645)

Event Date 07/31/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The device was not returned to physio-control. A third-party service agent performed an initial evaluation of the customer's device and verified the reported issue. Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803. 56. Device not evaluated by manufacturer.

Event Description

A third-party service agent contacted physio-control to report that their customer's device had failed its daily user test. Upon initial evaluation, by the service agent, it was observed that the device had logged an event code in its memory that is indicative of a device failure which could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform. The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level. There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 9076156
• MDR Text Key: 158815685
• Report Number: 0003015876-2019-01545
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K130454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 20
• Device Catalogue Number: 99402-000019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse