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	09/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the shift check, the autopulse platform (sn (b)(4) displayed user advisory (ua) 20 (position out of range) error message.No patient involvement.
Additional Manufacturer Narrative
Zoll has received the product for evaluation, however, the investigation is pending.A follow up report will be filed when the investigation has been completed.
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn (b)(6)) displayed a user advisory (ua) 20 (position out of range) error message was confirmed during archive data review and the initial functional testing.The root cause of the (ua) 20 was due to the driveshaft not being at the "home" position, most likely attributed to unintended user error.User advisories are normally clearable error messages and are designed into the platform to alert the operator that autopulse has detected one of several conditions.Per autopulse user advisory list guide, user advisory (ua) 20 occurs due to the encoder driveshaft not being within the normally acceptable range of positions.To clear a (ua) 20 error code, return the driveshaft to the home position using the administrative menu.A visual inspection of the returned platform was performed, and no physical damage was observed.The archive data was reviewed and showed several user advisory (ua) 20 error messages, thus confirming the reported complaint.The autopulse platform failed initial functional testing due to (ua) 20 displayed upon powering on.The driveshaft was rotated to the "home" position to clear the (ua) 20 error.Upon further testing, unrelated to the reported complaint, the autopulse platform failed the brake gap inspection due to the drive train motor brake assembly air gap being wide and out of specification, likely attributed to the device's aging.The brake gap was adjusted to the manufacturing specifications to remedy the issue.The autopulse platform was manufactured in 2011 and is 11 years old, past the expected service life of 5 years.Following service, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries without any fault or error.The brake gap inspection was performed and verified that the brake gap was within the specification.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 similar complaint reported for the autopulse platform with serial number (b)(6).

• 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: 15526334
• Report Number: 3010617000-2022-01722
• Device Sequence Number: 6055854
• Product Code: DRM
• UDI-Device Identifier: 00849111000598
• UDI-Public: 00849111000598
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2022

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: 8700-0730-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 10/02/2022
• Supplement Report FDA Received Date: 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2011
• 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