MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. AUTOPULSE®RESUSCITATION SYSTEM; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	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	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the autopulse platform (sn (b)(6)) displayed an error message upon powering up but did not report what user advisory (ua) or fault code was displayed.The platform's archive showed that the autopulse platform displayed multiple user advisory (ua) 17 (max motor on-time exceeded during active operation) and 02 (compression tracking error) on the customer's reported event date.The observed ua17 advisory was replicated during functional testing.Device inspection revealed that the drivetrain motor brake gap was too wide (out of the specification), triggering the intermittent occurrences of the ua02 and ua17 advisory messages.Visual inspection revealed a couple of physical damages, unrelated to the reported complaint.One of the screw bosses of the front enclosure was broken/cracked.One of the head restraint wires was almost detached from the surface of the top cover, but it did not render the autopulse platform non-functional.These observed physical damages are likely attributed to wear and tear.The autopulse platform was manufactured in december 2011, and it is over 12 years old, well beyond its expected service life of 5 years.The damaged parts need to be fixed/replaced to address the observed physical damages.Further review of the archive data did not show any other user advisories or faults on the reported event date.The autopulse platform failed initial functional testing due to ua17 advisory messages, confirming the reported complaint as the archive data verified that ua17 occurred multiple times on the customer's reported event date.The ua02 was not replicated during functional testing, but its intermittent occurrences with ua17 in the archive suggest that ua02 may be related to the brake gap being too wide; however, potential drivetrain motor malfunction cannot be ruled out.The too-wide (out of the specification) brake gap will need to be adjusted within the specification to address the intermittent occurrences of the ua17 and ua02 advisory messages.If adjustment of the brake gap does not remedy the problem, the drivetrain motor assembly will be replaced.Zoll is awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaints were reported for the autopulse platform with serial number (b)(6).
Event or Problem Description
The customer reported that during shift check, the autopulse platform (sn (b)(6)) displayed an error message upon powering up.The customer did not report what user advisory (ua) or fault code was displayed.No patient involvement.
Additional Manufacturer Narrative
Sections d1, d2, d3, d4, and g1 were corrected.No malfunction was found with the drivetrain motor.The too-wide (out of the specification) brake gap was adjusted within the specification to address the intermittent occurrences of the ua17 and ua02 advisory messages.Following service, the autopulse platform passed all testing criteria.

• Brand Name: AUTOPULSE®RESUSCITATION SYSTEM
• Common Device Name: CARDIAC RESUSCITATOR, LINE-POWERED
• Manufacturer (Section D): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 19038841
• Report Number: 3010617000-2024-00286
• Device Sequence Number: 18263468
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/26/2024

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: 100
• Device Catalogue Number: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2011
• 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