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

Model Number	100
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that upon installing the autopulse lifeband (lot # 206594), it was determined that the clip on the lifeband was damaged and wouldn't be installed correctly.Customer-provided photos showed a broken hinged belt guard.Upon receipt and investigation at zoll, the lifeband band clip (belt clip) was missing, which prevented the lifeband from being installed on the autopulse platform.No patient involvement.
Additional Manufacturer Narrative
The reported complaint that the autopulse lifeband (lot # 206594) wasn't installed correctly was confirmed during the visual inspection of the returned lifeband.The stitches securing the lifeband band clip (belt clip) were missing, and the belt clip itself was absent, preventing placement of the lifeband onto the autopulse platform driveshaft.Additionally, the hinged belt guard on one side was found to be loose.Visual inspection revealed that the belt clip was absent and that the stitches securing it on the lifeband were missing, likely due to user handling.The hinged belt guard on one side was loose because the locking pin was pushed away from the lifeband cover plate, preventing it from locking in place when moved to the flip-down position, likely due to the user's storage conditions for the lifeband.Upon further inspection, creases were noted on the lifeband belt surface, and one of the bands was partially ripped at the distant end of the lifeband belt, suggesting that the lifeband was used for an extended period of time.Functional testing could not be performed due to the lifeband condition, as the belt clip was missing.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaints reported for lifeband with lot # 206594.

• Brand Name: LIFEBAND® LOAD-DISTRIBUTING BAND
• Common Device Name: CARDIAC RESUSCITATOR BAND
• 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 ; 4084192347
• MDR Report Key: 23783935
• Report Number: 3010617000-2025-00835
• Device Sequence Number: 14722890
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2025

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: 100
• Device Catalogue Number: 8700-0701-01
• Device Lot Number: 206594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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