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

Model Number	MODEL 200
Medical Device Problem Codes	Retraction Problem (1536); Use of Device Problem (1670); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During patient resuscitation with the autopulse nxt platform, the crew observed a problem with an nxt band (lot #200888) that twists internally within the device even when correctly aligned on the patient.The failure occurred approximately 4 to 5 minutes into operation.A noticeable change in the sound of the autopulse motor was noted, indicating that the device was struggling and becoming bogged down.Shortly after, it stopped compressing.Upon attempting a reset, one side of the band was difficult to retract, revealing that it had become bundled within the device.Additionally, the outer sleeve of the band appeared to be pulled into itself.After resetting, the band quickly became tangled again due to the creases and folds that had formed.According to the customer, the patient was of average size.No further information was provided.The patient's status information was requested, but the customer did not provide a response.
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.The autopulse nxt band in the reported complaint will not be returned for investigation because the customer has disposed of it.Therefore, physical investigation could not be performed, and the root cause could not be determined.
Additional Manufacturer Narrative
Additional information in b5 (describe event or problem), and code update in h6 (health effect - clinical code and impact code).
Event or Problem Description
During patient resuscitation with the autopulse nxt platform, the crew observed a problem with an nxt band (lot #200888) that twists internally within the device even when correctly aligned on the patient.The failure occurred approximately 4 to 5 minutes into operation.A noticeable change in the sound of the autopulse motor was noted, indicating that the device was struggling and becoming bogged down.Shortly after, it stopped compressing.Upon attempting a reset, one side of the band was difficult to retract, revealing that it had become bundled within the device.Additionally, the outer sleeve of the band appeared to be pulled into itself.After resetting, the band quickly became tangled again due to the creases and folds that had formed.According to the customer, the patient was of average size.The crew reverted to manual cpr.No patient injuries were reported.

• 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 ; 4084192347
• MDR Report Key: 21755098
• Report Number: 3010617000-2025-00230
• Device Sequence Number: 10161747
• Product Code: DRM
• UDI-Device Identifier: 10849111002988
• UDI-Public: 10849111002988
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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: MODEL 200
• Device Catalogue Number: 8700-001013
• Device Lot Number: 200888
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 04/19/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/07/2025
• 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