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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that "the autopulse platform (s/n (b)(4) displayed "system error, out of service, revert to manual cpr" upon powering up" was confirmed during archive data review and functional testing.The root cause for the system error was that the drivetrain motor brake assembly air gap was too wide, out of specification.This caused the autopulse to stop functioning with a system error, per design.Also, the drivetrain brake area was noted heavily worn with the presence of dust and dirt inside the platform.The root cause for the reported complaint was likely attributed to maintenance.No documented report was found showing that regular preventative maintenance (pm) was performed on the autopulse platform.The lack of regular maintenance could degrade the mechanical components of the drivetrain.The drivetrain brake area was cleaned to remedy the observed issue.The autopulse platform was manufactured in january 2008 and is more than 14 years old, well past its expected serviceable life of 5 years.There was no physical damage observed on the returned autopulse platform during the visual inspection.However, unrelated to the reported complaint, the encoder driveshaft of the platform does not rotate smoothly and exhibits binding and resistance due to a sticky clutch plate.This type of driveshaft issue is characteristic of the normal use of the platform.The impact of a sticky clutch was not severe enough to make the platform non-functional.Deburring of the clutch plate was performed to remedy the encoder driveshaft issue.During initial functional testing, the returned autopulse platform displayed a "system error, out of service, revert to manual cpr" error message, thus confirming the reported complaint.The error was found to be due to the drive train motor brake assembly air gap was out-of-specification.The brake gap was adjusted to the manufacturing specifications to remedy the error message.The archive data revealed a system error 139 (unable to hold compression position) message on the reported event date, thus confirming the reported complaint.System error 139 was generated if a platform cannot give optimum cpr, the platform stopped compression as intended if it can't provide optimum cpr.In addition, the autopulse platform also displayed a user advisory (ua) 17 (max motor on time exceeded during active operation) error message, not related to the reported complaint, and was cleared by the user.After the service, 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 autopulse platform passed the final testing without any fault or error.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 sn (b)(4).
Event or Problem Description
During the shift check, the autopulse platform (sn (b)(4) displayed a "system error, out of service, revert to manual cpr" message.No patient involvement.

• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 14559283
• Report Number: 3010617000-2022-00592
• Device Sequence Number: 14688319
• Product Code: DRM
• UDI-Device Identifier: 00849111000079
• UDI-Public: 00849111000079
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 05/31/2022

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: 8700-0700-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2008
• 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