MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. AUTOPULSE BATTERY CHARGER; COMPRESSOR, CARDIAC, EXTERNAL

Model Number 100

Device Problem Positioning Problem (3009)

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

Event Date 08/23/2019

Event Type  malfunction  

Event Description

Difficult to place patient on autopulse device during a code blue in the cath lab.Required repositioning of patient and interruption in cpr.The device was not radiolucent in the cath lab and had to be removed to visualize the coronaries.

• Brand Name: AUTOPULSE BATTERY CHARGER
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): ZOLL CIRCULATION, INC.; 2000 ringwood ave; san jose CA 95131
• MDR Report Key: 9197340
• MDR Text Key: 162517252
• Report Number: 9197340
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 100
• Device Catalogue Number: 8700-0753
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22630 DA