MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 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 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

Physio-control performed an initial evaluation of the customers device and verified the reported issue.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.

Event Description

The customer contacted physio-control to report that their device provides abnormal energy delivery any time a shock is delivered.In this state the device will deliver an inappropriate defibrillation therapy if needed.There was no patient use reported with the event.

Manufacturer Narrative

Mdr [0003015876-2019-02084] was sent in error as a duplicate of mdr [0003015876-2019-02085].All supplemental information will be reported in mdr [0003015876-2019-02085].

Event Description

The customer contacted physio-control to report that their device provides abnormal energy delivery any time a shock is delivered.In this state the device will deliver an inappropriate defibrillation therapy if needed.There was no patient use reported with the 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
• MDR Report Key: 9526175
• MDR Text Key: 189357382
• Report Number: 0003015876-2019-02084
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K130454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• 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: UNK_SMP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1