MAUDE Adverse Event Report: DEFIBRILLATOR

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Atrial Fibrillation (1729); Death (1802)

Event Date 07/29/2016

Event Type  Death  

Event Description

My roommate had a heart attack while we were watching t.V.My daughter called 911 and i gave him c.P.R.When the paramedics arrived they hooked him to the machine and they said he was in a-fib.They attempted to shock him with their defibrillator twice.Nothing happened and i could see easily on their machine's screen in large letters "replace battery".They transported him to (b)(6), where they tried for half an hour to revive him, unsuccessfully.

• Brand Name: DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR
• MDR Report Key: 6030810
• MDR Text Key: 57567691
• Report Number: MW5065410
• Device Sequence Number: 1
• Product Code: MKJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NASAL SPRAY FOR ALLERGIES.; OTC MEDS: UNK; PARAMEDICS); RX MEDS: HIGH BLOOD PRESSURE; THREE OTHER UNKNOWN PRESCRIPTIONS (I GAVE THEM TO
• Patient Outcome(s): Death
• Patient Age: 67 YR
• Patient Weight: 68