MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.

Event Description

The autopulse platform (sn (b)(4)) displayed user advisory (ua) 17 (max motor on time exceeded), ua 16 (timeout moving to take-up position) , ua 2 (compression tracking error) and ua 7 (discrepancy between load 1 and load 2 too large) error messages.The reporter was unable to specify if the issue occurred during shift check or patient use.

Manufacturer Narrative

The primary report of the autopulse platform (sn (b)(4) displaying user advisory (ua) 17 (max motor on time exceeded) error message was confirmed during functional testing and archive review.The root cause of the issue was due to a defective drivetrain motor as a result of wear and tear.The secondary report of the platform displaying a ua 16 (timeout moving to take-up position) error message was not observed during functional testing and archive review.The tertiary report of the platform displaying a ua 2 (compression tracking error) error message was not reproduced during functional testing; however has an occurrence of a ua 2 error message in the archive review.Possible root cause were the mannequin was in the incorrect position or the life band was opened.The quaternary report of the platform displaying a ua 7 (discrepancy between load 1 and load 2 too large) error message was not observed during functional testing and archive review.Upon visual inspection of the platform, top and bottom covers were cracked.The probable cause for the physical damage was due to the normal wear and tear of the platform or due to the damage sustained by user mishandling.These observations are not related to the reported event.During archive data review, ua 17 and ua 2 error messages were observed.The platform was functionally tested and during initial power up, displayed a ua 17 error message which was attributed to a defective drivetrain motor.Upon replacing the top and bottom covers and drivetrain motor, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.The autopulse platform passed the final testing without any fault or error.Note that user advisory error messages are designed into the platform when one of several conditions is detected.Ua 2 alerts the operator that as the drive shaft rotates and shortens/tightens the lifeband (compresses the chest), the load sensors do not see the expected increase in load.This user advisory will persist until the patient is properly aligned.Per the autopulse user guide instruction, to clear the error message, the operator needs to pull up the lifeband until the chest bands are fully extended.Ensuring that the patient and the lifeband are aligned and then restarting the platform.Historical complaints were reviewed for service information related to the reported complaint and there were no similar complaints reported for autopulse with serial number (b)(4).

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8368251
• MDR Text Key: 137267438
• Report Number: 3010617000-2019-00119
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• 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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1