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

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the autopulse platform (sn (b)(4)) displayed "system error, out of service, revert to manual cpr" upon powering up.The customer rebooted the platform and replaced the battery but the issue was not resolved.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn (b)(4)) displayed the "system error, out of service, revert to manual cpr" error message was confirmed during initial functional testing and archive data review.The root cause for the system error was due to the defective processor board, as a result of the device's aging.The autopulse platform is a reusable device that was manufactured in october 2006 and is 16 years old, well beyond the expected service life of 5 years.During visual inspection, there was no physical damage observed on the autopulse platform.The archive data was corrupted due to the defective processor board, however, the system error 136 (internal parameter corrupted) error message was noted in the archive, thus confirming the reported complaint.During the initial functional test, the platform displayed a "system error, out of service, revert to manual cpr" error message during power on, thus confirming the reported complaint.To remedy the error message, the defective processor board needs to be replaced.The last autopulse 1.1 was manufactured in 2009.As of july 2016, zoll announced the end of life for autopulse 1.1.Many important components used in autopulse 1.1 are no longer available, further restricting our ability to service.The platform will be returned to the customer without the repair and it will have a label stating "not for clinical use" or will be scrapped.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for autopulse platform with serial number (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
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131
• MDR Report Key: 15541555
• Report Number: 3010617000-2022-01721
• Device Sequence Number: 6501800
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2022

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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2006
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown