MAUDE Adverse Event Report: ZOLL CIRCULATION INC 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)
Type of Reportable Event	Malfunction
Event or Problem Description
The autopulse platform (sn(b)(6)) displayed "system error, out of service, revert to manual cpr".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 that "autopulse platform (sn (b)(6)) displayed "system error, out of service, revert to manual cpr"" was confirmed based on the review of the archive data and during functional testing.The root cause of the reported complaint was the failed drive train, likely attributed to the aging of the device.The autopulse platform was manufactured in 2009 and is over 14 years old, past its expected service life of 5 years.Upon visual inspection, the power distribution board revision is up to date and the brake gap is within specification.Unrelated to the reported complaint, damage was observed on small black cover of the platform (the screw holder was broken on the inside).The observed physical damage appeared to be characteristic of user mishandling.The small black cover will be replaced to address the observed physical damage.The archive data review showed the occurrence of system error - 71 (motor drive train command issue), thus confirming the reported complaint.Unrelated to the reported complaint, fault 16 (timeout moving to take-up position) and user advisory (ua) 28 (loss of clutch connectivity) were also observed in the archive review.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering up the device, thus, confirming the reported complaint.The system error message was reset with apvision.After clearing the error memory with apvision, fault (16) occurred during a test run.The ua (28) observed in the archive was not reproduced.The system error - 71, fault 16, and ua (28) are attributed to the drive train failure.The drive train will be replaced to remedy the issues.Zoll is awaiting customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse with serial number (b)(6).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17148582
• Report Number: 3010617000-2023-00557
• Device Sequence Number: 5421513
• Product Code: DRM
• UDI-Device Identifier: 00849111000130
• UDI-Public: 00849111000130
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2023

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: 8700-0700-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2009
• 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