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 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

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

The customer contacted physio-control to report that their device logged a critical event code.The event code is indicative of a device issue that could result in a partial loss of defibrillator output energy due to a loss of the negative or positive 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.

Event Description

The customer contacted physio-control to report that their device logged a critical event code.The event code is indicative of a device issue that could result in a partial loss of defibrillator output energy due to a loss of the negative or positive 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.

Manufacturer Narrative

H6: the customer's device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.

• 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
• MDR Report Key: 8720516
• MDR Text Key: 149194428
• Report Number: 0003015876-2019-01067
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• 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: 99402-000089
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1