MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 BIPHASIC LIFEPAK® 500 AUTOMATED EXTERNAL DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number	99401-001084
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/23/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Physio control reviewed the device data and verified the reported issue.Physio determined that the use errors listed below was the cause of the reported issue.The user intended to press analyze but instead pressed power button at 3:21:05.The device was powered back on at 3:21:07, resulting in a 2 second delay.On four separate occasions the user was prompted by the device to ¿push analyze¿; at 3:20:47, 3:20:58, 3:21:10, and 3:21:21.The underlying cardiac rhythm was ventricular fibrillation (vf) at the time of each user voice prompt.It wasn¿t until the patient was transferred to a lifepak 15 that they received their first defibrillation, 4 minutes and 32 seconds into the case.The device was not returned to physio-control for evaluation.
Event or Problem Description
The customer contacted physio-control to report that a use error of selecting the power button instead of the analyse button caused a 2 minute delay in care and may have caused or contributed to a patient death.

• Brand Name: BIPHASIC LIFEPAK® 500 AUTOMATED EXTERNAL 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: 9078793
• Report Number: 0003015876-2019-01548
• Device Sequence Number: 2503072
• Product Code: MKJ
• UDI-Device Identifier: 00885074753980
• UDI-Public: 00885074753980
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K052057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 99401-001084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 49 YR