MAUDE Adverse Event Report: UNKNOWN DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number LIFEPAK20E

Device Problem Self-Activation or Keying (1557)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

During work, the nurse found that the defibrilator was automatically turned on and consumed electricity, which would affect the rescue use.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17530519
• MDR Text Key: 321353796
• Report Number: MW5137438
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: LIFEPAK20E
• Patient Sequence Number: 1