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)
Type of Reportable Event	Malfunction
Event or Problem Description
During the shift check, the autopulse platform sn (b)(6) displayed a user advisory (ua) 18 (max take-up revolutions exceeded) message.No patient involvement.
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.
Additional Manufacturer Narrative
The reported complaint of the autopulse platform sn (b)(6) displayed a user advisory (ua)18 (max take-up revolution exceeded) error message was confirmed during functional testing and based on the archive data review.The root cause of the ua18 error was due to a loose connector plug on the clutch, likely attributed to the device's aging, the device life expectancy is 5 years.The autopulse platform was manufactured in august 2015 and is almost 9 years old.The archive data indicated ua18 messages around the reported event date, thus, confirming the reported complaint.Functional testing could not be completed as the autopulse platform failed to execute the lifeband take-up and displayed the ua18 message, thus confirming the reported complaint.The connector plug on the clutch was reconnected to remedy the issue.Waiting for customer approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for the autopulse platform with sn (b)(6).Correction: d1 (brand name), d2 (common device name), d4 (model #), g1 (contact office).

• 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, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 19198687
• Report Number: 3010617000-2024-00376
• Device Sequence Number: 20922878
• Product Code: DRM
• UDI-Device Identifier: 00849111001076
• UDI-Public: 00849111001076
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 07/17/2024

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: 8700-0740-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2015
• 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