MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	1000
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and was unable to duplicate the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.They customer stated that they believe the issue with the device was related to the hair on the patient's chest (since skin prep was not performed) and the placement of the electrodes.The cause of the reported issue could not be conclusively determined.
Event or Problem Description
The customer contacted physio-control to report that during a cardiac arrest, their device would not recognize that a (b)(6) year old male was connected.The customer reported that the patient had an excessive amount of hair on their chest and they had not completed skin prep to the chest prior to electrode placement.The crew brought out a second device, with minimal delay and a new set of electrode pads were attached to the patient.They were able to deliver a shock to the patient; however the patient did not survive the event.The customer reported that the issue with their device did not cause or contribute to the outcome of the patient since they were able to deliver a shock to the patient using their second device.
Additional Manufacturer Narrative
After further review of the information available, it is likely that the cause of the reported issue was due to use error.The operating instructions state: " if the chest is excessively hairy, quickly shave the hair in the area where you will place the pads." if the user does not remove hair from the site of electrode placement prior to attaching the electrodes, there may be poor electrode-to-skin contact.This will result in the device prompting the user to "connect electrodes".
Event or Problem Description
The customer contacted physio-control to report that during a cardiac arrest, their device would not recognize that a (b)(6) male was connected.The customer reported that the patient had an excessive amount of hair on their chest and they had not completed skin prep to the chest prior to electrode placement.The crew brought out a second device, with minimal delay and a new set of electrode pads were attached to the patient.They were able to deliver a shock to the patient; however the patient did not survive the event.The customer reported that the issue with their device did not cause or contribute to the outcome of the patient since they were able to deliver a shock to the patient using their second device.
Event or Problem Description
The customer contacted physio-control to report that during a cardiac arrest, their device would not recognize that a 55 year old male was connected.The customer reported that the patient had an excessive amount of hair on their chest and they had not completed skin prep to the chest prior to electrode placement.The crew brought out a second device, with minimal delay and a new set of electrode pads were attached to the patient.They were able to deliver a shock to the patient; however the patient did not survive the event.The customer reported that the issue with their device did not cause or contribute to the outcome of the patient since they were able to deliver a shock to the patient using their second device.
Additional Manufacturer Narrative
Field e4 initial report sent to fda of the initial mdr should have indicated ¿ no.

• Brand Name: LIFEPAK® 1000 DEFIBRILLATOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 7696127
• Report Number: 0003015876-2018-01132
• Device Sequence Number: 646028
• Product Code: MKJ
• UDI-Device Identifier: 00885074698878
• UDI-Public: 00885074698878
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1000
• Device Catalogue Number: 99425-000023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 08/22/2018; 03/31/2020
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 08/24/2018; 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR