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

Model Number	100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During servicing, the loaner autopulse platform (sn (b)(6) was found to have a damaged encoder shaft that could impact device functionality.The encoder shaft should remain in the home position and move only when a lifeband belt clip is inserted, and compression is initiated.Upon receipt from the customer, the autopulse platform's shaft was in the home position, and the platform passed functional testing without issues.However, observed damage to the encoder shaft presents a risk of unintended movement out of the home position, which could trigger a user advisory 45 (not at "home" position after power-on/restart) error.Therefore, replacement of the integrated encoder gearbox is required to mitigate this risk.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 servicing, the loaner autopulse platform (sn (b)(6) was found to have a damaged encoder shaft that could impact device functionality.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: 24225983
• Report Number: 3010617000-2026-00047
• Device Sequence Number: 9293443
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2026

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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2012
• 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