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

Model Number	MODEL 200
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.The customer reported complaint that the nxt platform (sn (b)(6) "took up slack" in the nxt band (lot # 211084) was confirmed during the visual inspection of the returned nxt band.It was observed that the belt on the right side was twisted and jammed, along with the tyvek liner in the band guard, likely due to user mishandling.This observed issue causes the band to pull inward on one side during compression or decompression, resulting in a noticeable "slack" effect on the opposite side.Per the autopulse nxt user guide warnings and cautions, ensure the autopulse band is properly aligned with the patient's armpits at the platform's yellow reference line and verify that the band and straps are not twisted before initiating compressions.Functional testing could not be performed due to damage observed on the returned nxt band.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaints reported for nxt band with lot # 211084.The death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr, adjunctive use only indication is prominently displayed on device labels and in the device manual.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions when effective manual cpr is not possible.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.The autopulse is intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the trained user reverts to manual cpr.The transition from autopulse to manual cpr by trained users is similar to the time necessary for rescuer rotation and presents the same workflow as manual cpr.Hence, based on available information, the patients' outcome was not negatively impacted by the interruptions when compared to standard of care manual cpr.According to multiple studies, out-of-hospital cardiac arrest (ohca) is considered one of the leading causes of death in industrialized nations, with a significant number of deaths occurring outside of a hospital setting, making it a major public health concern; this information is supported by research from the cdc, studies on global mortality rates, and data from various cardiac arrest registries.Survival to hospital discharge after non-traumatic emergency medical services-treated cardiac arrest with any first recorded rhythm was around 10% for patients of any age (mozaffarian, circulation, 2016; ebiomedicine 2023).Death is an expected outcome for ohca.
Event or Problem Description
The event involved a 91-year-old male (approx.165 lbs) at a private residence.The cardiac arrest was presumed to be cardiac in origin with no observed signs of trauma.The arrest was unwitnessed, with the patient last known conscious approximately 30 minutes before discovery.No bystander cpr was performed.Upon arrival, another responding agency performed manual cpr for approximately 6 minutes before attempting to deploy the autopulse nxt platform.During deployment, the platform (sn (b)(6) took up slack in the nxt band (lot # 211084) but then stopped and failed to initiate compressions.Following the device failure, the crew immediately transitioned back to manual cpr for approximately 12 minutes.Rosc was not achieved.The patient was pronounced deceased in the kitchen of the residence by an emergency department physician via telephone; the cause of death remains unknown.No detrimental effects attributable to the nxt platform were identified.Upon return to the station, the event log was downloaded via usb from the nxt platform and showed fault 1210 (fault_motor_sensor_low_during_compres).

• 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: 24600038
• Report Number: 3010617000-2026-00203
• Device Sequence Number: 9606084
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/14/2026

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: 211084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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: Male
• Patient Weight: 75 KG