MAUDE Adverse Event Report: ZOLL ZOLL DEFIBRILLATOR PADDLES (INTERNAL)

Model Number 8011013904

Device Problem Device Stops Intermittently (1599)

Patient Problem Death (1802)

Event Date 07/09/2015

Event Type  Death  

Event Description

The pt had a redo coronary artery bypass graft (cabg) on (b)(6) 2015.At the end of the procedure, her pupils were fixed and dilated.On (b)(6) 2015 at 6:30am, the surgeon noted the pt's prognosis to be "grim".On (b)(6) 2015 at approx 12:20pm, the pt's chest was opened to determine if she was bleeding from her thoracic cavity.At approx 1:06pm, the pt coded.During the code, the internal defibrillator paddles intermittently.The pt did receive three shocks.The pt was pronounced dead at 1:15pm.Though the paddles/defibrillator intermittently failed, it was not felt this caused the death.

• Brand Name: ZOLL DEFIBRILLATOR PADDLES (INTERNAL)
• Type of Device: ZOLL DEFIBRILLATOR PADDLES (INTERNAL)
• Manufacturer (Section D): ZOLL; chelmsford MA 01824
• MDR Report Key: 4935546
• MDR Text Key: 6015871
• Report Number: MW5044601
• Device Sequence Number: 2
• Product Code: LDD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/18/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8011013904
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 41 YR