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

Model Number	MODEL 100
Medical Device Problem Codes	Use of Device Problem (1670); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During service, the autopulse platform (sn 21466) displayed user advisory (ua)45 (not at "home" position after power-on/restart) and ua02 (compression tracking error) messages.In addition, the load cell reading kept fluctuating.The observed ua45 and ua02 were found to be caused by the failed integrated encoder gearbox, likely attributed to the age of the autopulse platform.The observed load cell reading fluctuation was caused by a failed load cell.The cracked top cover and a load cell failure were likely attributed to mishandling, such as a drop, or the age of the autopulse platform.The autopulse platform was manufactured in 2014 and is nine years old, well past the expected serviceable life of five years.Upon visual inspection, one of the head restraints on the top cover was found to be detached, and a large crack was noted on the front enclosure, likely attributed to user mishandling, such as a drop.Missing or detached head restraints do not render the autopulse platform non-functional.The head restraint wire could have been cut to free the patient from the platform, or the user could have been lifting the platform by holding the head restraints.The platform is nine years old; therefore, the contribution of aging could not be ruled out.The integrated encoder gearbox and the load cell needs to be replaced to address the observed uas and load cell reading fluctuation.The top cover and front enclosure need to be replaced to address the observed physical damages.Zoll is awaiting customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaint was reported for the autopulse platform with sn (b)(4).
Event or Problem Description
During servicing on (b)(6) 2023, the autopulse platform (sn (b)(4)) displayed user advisory (ua)45 (not at "home" position after power-on/restart) and ua02 (compression tracking error) messages.In addition, the load cell reading kept fluctuating.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: 16480935
• Report Number: 3010617000-2023-00288
• Device Sequence Number: 3135830
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/03/2023

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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2014
• 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