MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. LIFEBAND® LOAD-DISTRIBUTING BAND; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	MODEL 200
Medical Device Problem Codes	Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released the autopulse nxt band associated with this complaint was discarded by the customer.Since the device was not returned, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
The customer reported that the autopulse nxt band (lot# unknown) failed by snapping during a cardiac arrest event.No additional device failures were reported.The patient's status information was requested but the customer did not provide a response.
Additional Manufacturer Narrative
Correction: h1, type of reportable event.
Additional Manufacturer Narrative
The reporter did not provide information on whether any adjustments were made to the nxt band during the call, nor did they provide details to clarify the circumstances that led to the nxt band failure.Review of the submitted photographs shows damage patterns consistent with a twisted belt, likely due to user mishandling.The belt fibers appear frayed but clean, indicating progressive wear rather than an abrupt cut.This type of damage would have developed over an extended period before failure occurred.Per the autopulse nxt user guide, the nxt band must be correctly aligned with the platform, not twisted, firmly secured on both sides, positioned at 90 degrees to the platform, and free of obstructions from arms, clothing, straps, or buckles that could interfere with band movement.

• Brand Name: LIFEBAND® LOAD-DISTRIBUTING BAND
• 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: 24229584
• Report Number: 3010617000-2026-00068
• Device Sequence Number: 9220918
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2026

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: MODEL 200
• Device Catalogue Number: 8700-001013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 02/19/2026; 03/19/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/18/2026; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown