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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that "the autopulse platform (sn (b)(4)) displayed a user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message" was confirmed during functional testing and based on the review of the archive data.The root cause of the ua07 advisory message was the defective load cell modules, likely attributed to mishandling such as a drop or a defective component.During visual inspection, unrelated to the reported complaint, the encoder driveshaft could not rotate smoothly, exhibiting binding and resistance.The cause for the sticky clutch could be due to normal wear and tear.The impact of a sticky clutch was not severe enough to make the platform non-functional.The autopulse platform was manufactured in 2016 and is 5 years old.The clutch plate needs to be deburred to address the observed problem.A review of the archive data showed multiple user advisory (ua) 07 (discrepancy between load 1 and load 2 too large); thus, confirming the reported complaint.Functional testing failed due to the ua07 advisory message displayed upon powering up the platform; thus, confirming the reported complaint.A load cell characterization test was performed and confirmed both load cell modules as defective, and the load cells needs to be replaced to remedy the 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 serial number (b)(4).
Event or Problem Description
During shift check, the autopulse platform (sn (b)(4)) displayed a user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose 93151
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose 95131 ; 4084192922
• MDR Report Key: 13538939
• Report Number: 3010617000-2022-00159
• Device Sequence Number: 4312888
• Product Code: DRM
• UDI-Device Identifier: 00849111001090
• UDI-Public: 00849111001090
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 02/15/2022

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: 8700-0740-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2016
• 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