MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control performed an initial evaluation of the customer¿s device but was unable to duplicate 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.Physio-control contacted the customer to request additional information on the patient.The customer informed physio-control that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.
Event or Problem Description
The customer contacted physio-control to report that the shock button on their device was inoperable during patient use.The customer advised that the device did not deliver the shock after the shock button was pressed.Another device was used to continue patient care.In this state defibrillation therapy would be unavailable if needed.This issue is patient related; however there was no adverse patient outcome reported.
Event or Problem Description
The customer contacted physio-control to report that the shock button on their device was inoperable during patient use.The customer advised that the device did not deliver the shock after the shock button was pressed.Another device was used to continue patient care.In this state defibrillation therapy would be unavailable if needed.This issue is patient related; however there was no adverse patient outcome reported.
Additional Manufacturer Narrative
Physio-control further evaluated the customer's device and was unable to duplicate the reported issue.As a precaution the main keypad assembly was replaced.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.Physio downloaded and reviewed the electronic records from the device.There was no log of the shock button being pressed.The device did dump its energy twice, however those events were caused by the user by pressing the energy down button.The removed main keypad assembly was further evaluated and the resistance reading was below the value that could affect its function.The root cause of the reported issue could not be conclusively determined.It is possible that the cause could be related to use error or to increased resistance on the shock button.

• Brand Name: LIFEPAK(R) 15 MONITOR/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: 10022844
• Report Number: 0003015876-2020-00603
• Device Sequence Number: 16883107
• Product Code: MKJ
• UDI-Device Identifier: 00883873884348
• UDI-Public: 00883873884348
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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: 15
• Device Catalogue Number: 99577-001372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2020
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1