MAUDE Adverse Event Report: ZOLL MEDICAL CORP. AUTOPULSE CPR ; COMPRESSOR, CARDIAC EXTERNAL

Model Number 100

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2018

Event Type  Death  

Event Description

Autopulse cpr device paused on the usage of a pt during a code, and after the device was adjusted by personnel.

• Brand Name: AUTOPULSE CPR
• Type of Device: COMPRESSOR, CARDIAC EXTERNAL
• Manufacturer (Section D): ZOLL MEDICAL CORP. ; san jose CA 95131
• MDR Report Key: 8101607
• MDR Text Key: 128395248
• Report Number: MW5081565
• 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
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• 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): Death; Hospitalization
• Patient Age: 67 YR
• Patient Weight: 75