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	03/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the platform for investigation.A follow-up report will be submitted when the product is returned, and the investigation has been completed.
Event or Problem Description
During the shift check, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 28 (loss of clutch connectivity) and fault code 29 (loss of brake connectivity) error messages, and the platform will not perform chest compressions.No patient involvement.
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (sn (b)(6) displayed user advisory (ua) 28 (loss of clutch connectivity) and fault code 29 (loss of brake connectivity) error messages was confirmed during functional testing and in the archive data review.The root cause of reported errors was the failed power distribution board (pdb), likely attributed to an aging device.The autopulse platform was manufactured in september 2016 and is more than 6 years old, and has exceeded its expected service life of 5 years.During the visual inspection of the platform, the load plate cover had a hole, which affects the watertight seal.The observed physical damage was unrelated to the reported complaint and appeared to be characteristic of user mishandling.The load plate cover needs to be replaced to address the issue.A review of the archive showed (ua) 28 and fault code 29 (loss of brake connectivity) error messages, thus confirming the customer's reported complaint.During functional testing, the autopulse platform did not engage the break when powered on and displayed (ua) 28 and the fault code 29 error messages, thus confirming the customer's reported complaint.Investigation revealed a failed pdb.The pdb needs to be replaced to remedy the faults.During further functional testing, unrelated to the reported complaint, a brake gap inspection was performed, and discovered that the brake gap was too wide, and out of specification.The brake gap needs to be cleaned and adjusted to remedy the fault.In addition, during the testing, unrelated to the reported complaint, a very irregular movement of the encoder shaft was observed due to encoder bearing damage, likely attributed to the age of the device.The encoder needs to be replaced to address the issue.Waiting for the customer's approval for service repair.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 16839985
• Report Number: 3010617000-2023-00380
• Device Sequence Number: 6889081
• Product Code: DRM
• UDI-Device Identifier: 00849111001151
• UDI-Public: 00849111001151
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: 8700-0740-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2016
• 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