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	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "the autopulse platform (sn (b)(4)) displayed fault code 27 (encoder fault (> 3000 rpm)) error message" was confirmed based on the review of the archive data and during functional testing.The root cause for the reported complaint was the failed encoder, likely attributed to normal wear and tear.The autopulse platform is a reusable device that was manufactured in (b)(6) 2008 and is 15 years old, well past the expected serviceable life of 5 years.During visual inspection, no physical damage was observed.Based on archive data review, several fault code 27 messages were observed, thus confirming the reported complaint.Also, unrelated to the reported complaint, fault code 16 (timeout moving to take-up position) were recorded.The fault code 16 error was not replicated during functional testing, however; the root cause was the drive train motor brake assembly air gap was out of specification and was not adjustable, likely attributed to normal wear and tear.The autopulse platform is a reusable device that was manufactured in (b)(6) 2008 and is15 years old, well past the expected serviceable life of 5 years.The drive train motor needs to be replaced to address the fault code 16 error observed in the archive.The autopulse platform failed initial functional testing due to fault code 27 (encoder fault (> 3000 rpm)) error message upon powering on, thus, confirming the reported complaint.The root cause for the reported complaint was the failed encoder.The encoder needs to be replaced to address the reported complaint.Zoll awaiting customer's approval for service repair.Historical complaints were reviewed for service information related to the reported complaint and there were no similar complaints reported for autopulse platform with sn (b)(4).
Event or Problem Description
During patient use, the autopulse platform (sn (b)(4)) displayed fault code 27 (encoder fault (> 3000 rpm) error message after five compressions.Manual cpr was performed.No consequences or impact to the patient.

• 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 nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 16637575
• Report Number: 3010617000-2023-00299
• Device Sequence Number: 17501646
• 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): 03/29/2023

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: 8700-0700-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 03/29/2023
• 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