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

Model Number	MODEL 100
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the product for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
During shift check, the autopulse platform (sn (b)(4)) displayed a "system error, out of service, revert to manual cpr" message upon power up.Additionally, the user observed damaged head restraint bracket.No patient involvement.
Additional Manufacturer Narrative
The report of the autopulse platform (sn (b)(4)) displaying a "system error, out of service, revert to manual cpr" error message was confirmed during functional testing and archive data review.Root cause was determined to be a communication error.The platform was connected to the autopulse vision software and the error message was able to be cleared.The reported complaint of a damaged head restraint wires was confirmed during visual inspection of the returned autopulse platform.To remedy the issue, the top cover was replaced.The platform failed the initial functional testing due to system error (latch error 139 - unable to hold compression position) was observed upon powering up the device.As part of routine service during testing, the platform was examined and found damaged load plate cover, bent battery latch lock and stiff drive shaft when rotated due to sticky clutch.The observed physical damages were unrelated to the reported event.After replacement of the damaged parts and deburring the clutch, the platform was further tested including the load characterization check and passed the testing.The platform operated with continuous compression on both the normal and large resuscitation fixture without any issues or error messages observed.The autopulse platform is a reusable device and was manufactured in 2011.Therefore, this type of physical damage found during visual inspection is characteristic of normal wear and tear for the life of the device.The device has exceeded its expected service life of 5 years.The archive data was reviewed and contained a system error message, thus confirming customer complaint.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7575971
• Report Number: 3010617000-2018-00619
• Device Sequence Number: 11333200
• Product Code: DRM
• UDI-Device Identifier: 00849111000154
• UDI-Public: 00849111000154
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2018

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1