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

Model Number	MODEL 100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the autopulse platform in complaint for investigation.A follow-up report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
During shift check, the customer noticed that the autopulse platform (sn 31271) emitted a burning smell upon powering up.The platform functions as intended, aside from the burning smell.The customer could not locate where the burning smell was coming from.No patient involvement.
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (sn (b)(6)) emitted a burning smell upon powering up was not confirmed during functional testing.The autopulse platform functioned as intended.Visual inspection of the returned autopulse platform revealed that the bottom enclosure was cracked, unrelated to the reported complaint.The top cover and the front enclosure were replaced to remedy the damage.This type of physical damage could be attributed to wear and tear.The autopulse platform was manufactured in january 2010 and is over 14 years old, well beyond its expected service life of 5 years.The bottom enclosure needs to be replaced to address the observed issue.During further device check, a brake gap inspection revealed that the drivetrain motor brake gap was slightly wide, out of specification, unrelated to the reported complaint.This issue is most likely attributed to wear and tear and did not render the autopulse platform non-functional.The brake gap needs to be adjusted to remedy the problem.The archive data review showed no significant discrepancies.The autopulse platform passed initial functional testing without any fault or error.The customer's reported complaint was not replicated.

• 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: 18681487
• Report Number: 3010617000-2024-00141
• Device Sequence Number: 17678157
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2010
• 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