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 Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that after a patient call, when the crew attempted to replace the autopulse nxt band (lot # 226137), they noticed the band's blue plastic belt had scrunched up.Based on the pictures provided by the customer, the band's tyvek liner was torn, twisted, and jammed into the band guard.The autopulse nxt platform itself turned on without any issues, displayed no error codes or messages, and functioned properly throughout the call.The damaged band remained in use throughout the entire call, and the crew discarded it afterward.No consequences or impact on the patient.
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.Zoll did not receive the autopulse nxt band in the complaint for evaluation because the customer had discarded it.However, a review of the customer-provided pictures showed that both sides of the belt were twisted and jammed within the band guard.The twisted belt appeared to have pulled the protective tyvek liner sheath into the band guard opening, likely due to improper handling.

• 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: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; +1(408)419-2347
• MDR Report Key: 50876680
• Report Number: 3010617000-2026-00593
• Device Sequence Number: 16138155
• Product Code: DRM
• UDI-Device Identifier: 00849111002981
• UDI-Public: 00849111002981
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 226137
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2026
• 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