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	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During shift check, customer reported that the autopulse platform (serial #(b)(4) displayed "system error, out of service, revert to manual cpr " message.No patient involvement.
Additional Manufacturer Narrative
The customer reported a complaint that "the autopulse platform (sn(b)(4) displayed a "system error, out of service, revert to manual cpr" message," which was confirmed during the functional testing and the archive data review.The root cause of the system error was the drivetrain motor brake gap was too wide, out of specification, likely due to age of the device.The autopulse platform was manufactured in 2008 and is 15 years old, well beyond its expected serviceable life of 5 years.During visual inspection, there was no physical damage observed on the autopulse platform.A review of the archive data showed a system error, 139 (unable to hold compression position); thus, confirming the reported complaint.Also in the archive, unrelated to the reported complaint, user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) recorded.The load cell needs to be replaced to address this ua 07 error.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.Investigation revealed the root cause of the system error was the drivetrain motor brake gap was too wide, out of specification, likely due to age of the device.The defective drivetrain motor assembly needs to be replaced to address the system error.Upon further functional testing and unrelated to the reported complaint, the load cell characterization indicated single point load cell module 1 failed.The failed load cell needs to be replaced to address the ua07.Following service, a load cell characterization test was performed again, confirming that both cell modules function within the specification.The autopulse platform was subjected to a final run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without any fault or error.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 complaints reported for autopulse platform with sn (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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 16461140
• Report Number: 3010617000-2023-00181
• Device Sequence Number: 2343494
• Product Code: DRM
• UDI-Device Identifier: 00849111000116
• UDI-Public: 00849111000116
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/01/2023

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: 8700-0700-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 03/01/2023
• 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