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	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During preventative maintenance, the autopulse platform (sn (b)(6) failed functional testing due to fault 41 (patient temperature sensor failure).The root cause of the observed failure was a failed temperature sensor.The temperature sensor needs to be replaced to address fault 41.The archive data review indicated user advisory 17 (max motor on time exceeded during active operation) and ua29 (loss of brake connectivity) error messages.The power distribution board needs to be replaced to address the observed uas in the archive.The customer declined the service repair.Therefore, no service was performed, and the autopulse platform will be scrapped at zoll.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaint was reported for the autopulse platform with sn (b)(6).
Event or Problem Description
During preventative maintenance, the autopulse platform (sn (b)(6) failed functional testing due to fault 41 (patient temperature sensor failure).No patient involvement.

• 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 ; 4084192347
• MDR Report Key: 23043182
• Report Number: 3010617000-2025-00617
• Device Sequence Number: 9890012
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2015
• 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