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

Model Number	100
Medical Device Problem Codes	Fitting Problem (2183); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6 (adverse event problem) was updated.The reported complaint that the back casing of the autopulse platform (sn (b)(6)) that goes over the rotator comes away far too easily, and the lifeband kept popping off from the back of the platform was not confirmed during visual inspection or functional testing.The customer reported problem could not be reproduced and the platform performed as intended.The secondary complaint that the platform displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error messages was confirmed during archive review and functional testing.According to the customer, the ua45 was previously cleared.However, during functional testing at zoll, the platform displayed ua45 error message that could not be cleared, due to a failure of the encoder.Visual inspection was performed and found no physical damage to the returned autopulse platform.A review of the archive data showed ua45, confirming the reported complaint.The autopulse platform failed the initial functional testing due to the ua45 displayed upon powering on.The drive shaft could not be adjusted to the home position due to the defective encoder.The integrated encoder gearbox was replaced to remedy the problem.Following service, the autopulse platform passed the run-in test without any fault or error.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint of ua45, and no similar complaints were reported for the autopulse platform with sn (b)(6).
Additional Manufacturer Narrative
Zoll has not received the autopulse platform in the complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
The customer reported the back casing of the autopulse platform (sn (b)(6) that goes over the rotator comes away far too easily.During arrest the other day and the lifeband kept popping off from the back of the platform.It was pointed out that the band is not fitting properly and can easily be pulled out.Use of the platform was discontinued, and a lucas device was used.After the arrest the customer took the lifeband off, checked it was placed on correctly and tried it on a dummy and there were no issues.No device malfunction is suspected for the lifeband.Prior to the event, in training, they were experiencing user advisory (ua) 45 (not at "home" position after power-on/restart) error messages, but electromed department reported the errors appeared to have been cleared.No patient harm reported.

• 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 ; 4084192922
• MDR Report Key: 21579518
• Report Number: 3010617000-2025-00178
• Device Sequence Number: 21136594
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/08/2025

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: 8700-0740-01
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2016
• 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