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

Model Number	100
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lifeband involved in the reported complaint will not be returned for investigation because the customer has disposed of it.Therefore, a physical investigation could not be performed, and the root cause could not be determined.
Event or Problem Description
Patient # 2: during the resuscitation attempt using the autopulse platform (sn (b)(6), the lifeband (lot #198870) tore apart while in use.The crew performed manual cpr for the rest of the call.No consequences or impacts on the patient.

• 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 21931328
• Report Number: 3010617000-2025-00312
• Device Sequence Number: 8650776
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2025

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: 198870
• 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: 04/03/2025
• Initial Report FDA Received Date: 04/29/2025
• 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