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

Model Number 20E

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

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 during a patient event, the device advised a shock to the patient when it was not needed and they were unable to change the device from aed mode into manual mode.The patient, an (b)(6) male, had been admitted into the hospital due to aspiration pneumonia.During his stay at the hospital, he went into cardiac arrest and the device was connected to the patient using conmed padpro therapy electrodes via a quik-combo therapy cable.The customer advised that two shocks were delivered to the patient with the device in aed mode and rosc was achieved.The device continued to analyze and advised a shock to be delivered.The doctor felt that the patient was in a good rhythm and did not need the shock.It was attempted to change the device from aed mode to manual mode.The device kept showing that it was in aed mode and advised a shock so the doctor delivered the shock.The third shock was delivered and sparks were seen coming from where the pads were connected to the patient.The customer advised that there was no skin prep performed on the patient's chest and his skin was dry and scaly.Upon removing the therapy electrodes, it was observed that the patient's skin was reddened and blackened.The patient was moved into the icu where he later expired.The doctor and medical personnel do not believe that the device use contributed to the patient¿s outcome, telling physio-control that rosc was achieved after the second shock.The patient was moved to the icu and his health continued to deteriorate.The family decided for medical personnel to provide comfort measures for the patient and the patient expired.

Manufacturer Narrative

Physio-control evaluated the customer's device and was unable to duplicate the reported issue.Physio was not able to download the patient files from the device.Without the patient file, it cannot be confirmed whether the device was unable to be changed into manual mode, or whether the device provided an incorrect shock advised decision.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.The cause of the reported issue could not be determined.

Event Description

The customer contacted physio-control to report that during a patient event, the device advised a shock to the patient when it was not needed and they were unable to change the device from aed mode into manual mode.The patient, an (b)(6) year old male, had been admitted into the hospital due to aspiration pneumonia.During his stay at the hospital, he went into cardiac arrest and the device was connected to the patient using conmed padpro therapy electrodes via a quik-combo therapy cable.The customer advised that two shocks were delivered to the patient with the device in aed mode and rosc was achieved.The device continued to analyze and advised a shock to be delivered.The doctor felt that the patient was in a good rhythm and did not need the shock.It was attempted to change the device from aed mode to manual mode.The device kept showing that it was in aed mode and advised a shock so the doctor delivered the shock.The third shock was delivered and sparks were seen coming from where the pads were connected to the patient.The customer advised that there was no skin prep performed on the patient's chest and his skin was dry and scaly.Upon removing the therapy electrodes, it was observed that the patient's skin was reddened and blackened.The patient was moved into the icu where he later expired.The doctor and medical personnel do not believe that the device use contributed to the patient¿s outcome, telling physio-control that rosc was achieved after the second shock.The patient was moved to the icu and his health continued to deteriorate.The family decided for medical personnel to provide comfort measures for the patient and the patient expired.

• Brand Name: LIFEPAK® 20E 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: 7665479
• MDR Text Key: 113303357
• Report Number: 0003015876-2018-01053
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873887707
• UDI-Public: 00883873887707
• Combination Product (y/n): N
• PMA/PMN Number: K130454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20E
• Device Catalogue Number: 99507-000102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR