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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

During the shift check, the auto pulse platform sn (b)(4)) displayed a "system error, out of service, revert to manual cpr" error message.No patient involvement.

Manufacturer Narrative

The customer's reported complaint of the autopulse platform (sn 23704) displayed a "system error, out of service, revert to manual cpr" error message was confirmed during archive data review and during functional testing.The root cause for the reported complaint was due to defective drivetrain motor.A replacement of the drivetrain motor is required to remedy the problem.As part of routine service during testing, the platform was examined and found the load plate cover defected with the hole that affects the watertight seal.The observed damage is unrelated to the reported complaint.The load plate cover needs to be replaced to address the issue.This type of physical damage found during visual inspection is characteristic of user mishandling.The autopulse platform failed initial functional testing due to "system error, out of service, revert to manual cpr" error message displayed upon powering on.The error was found due to the drive train motor brake assembly air gap was too wide, measured at 0.012" out of the specification of (0.008" ± 0.001").Performed brake gap adjustment, however, the gap was not adjustable and continued to open out of specification.The encoder was removed from the drive train motor and found broken socket head cap screw which locks the clutch rotor to the clutch.This failure caused the brake gap to be out of specification.The archive data revealed a system error 139 (unable to hold compression position) message on the reported event date, thus confirming the reported complaint.Upon customer approval, the damaged parts will be replaced.The platform will be further tested to full specification.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for autopulse platform sn (b)(6).Ccr 44979, reported on (b)(6) 2019, the drivetrain motor was replaced.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 9527689
• MDR Text Key: 179287900
• Report Number: 3010617000-2019-01173
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• 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: 02/28/2020

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 02/21/2020
• Supplement Dates FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1