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

Model Number LIFEPAK 15

Device Problems Failure to Deliver Shock/Stimulation (1133); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Arrhythmia (1721)

Event Date 11/21/2022

Event Type  Injury  

Event Description

Lifepak 15 defib/ monitor failed to deliver a therapy on (b)(4) joules via pads 3 times.The patient was then defibrillated with paddles from the same unit, however the patient did not appear to receive the full therapy during that time.The patient did cardiovert to a normal rhythm and this unit was replaced with another one we had in the department and is currently in biomed waiting on clearance to be checked and serviced.

• Brand Name: PHYSIO-CONTROL LIFEPAK 15 DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC
• MDR Report Key: 15933206
• MDR Text Key: 305134382
• Report Number: MW5113683
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/05/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: LIFEPAK 15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White