MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. ZOLL AUTOPULSE

Model Number AUTOPULSE

Device Problems Overheating of Device (1437); Loss of Power (1475); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

While using a trial autopulse on a patient a crew member blocked an air vent with their knee causing the device to overheat and shut down.Device was out for no more than 30 seconds and was restarted and used without issue afterwards.

• Brand Name: ZOLL AUTOPULSE
• Type of Device: ZOLL AUTOPULSE
• Manufacturer (Section D): ZOLL CIRCULATION, INC.
• MDR Report Key: 7577558
• MDR Text Key: 110502684
• Report Number: MW5077674
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AUTOPULSE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 38 YR
• Patient Weight: 54