MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/06/2018

Event Type  malfunction  

Manufacturer Narrative

The reported complaints were not confirmed.However, other faults were identified during the archive review and functional testing of the autopulse platform.The archive data indicated multiple faults of ua12 (lifeband not detected) on (b)(6) 2018 and ua02 (compression tracking error), ua17 (motor on for too long during active operation), and ua45 (drive shaft not at home position) on (b)(6) 2018.There was no indication of ua18 in the archive data and device being power up on the date problem reported on (b)(6) 2018.During functional testing the device failed and displayed ua17 error message within 2 minutes of compression.Replace defective drivetrain (brake gap is out of spec and not adjustable) to remedy the fault.Further functional testing was performed and the device performed as intended.

Event Description

The autopulse platform displayed ua18 (max take-up revolution exceeded) error message during shift check.In addition, the drive shaft was observed to be not rotating.No patient involved.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer Contact: kim nguyen ; 2000 ringwood avenue; san jose, CA 95131
• MDR Report Key: 7489582
• MDR Text Key: 107593672
• Report Number: 3010617000-2018-00524
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Emergency Medical Technician
• Type of Report: Initial
• Report Date: 05/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 05/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1