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

Model Number	100
Medical Device Problem Codes	Material Integrity Problem (2978); 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 associated with this complaint was discarded by the customer.Since the lifeband was not returned, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
The customer reported that during patient use, the autopulse platform (sn: (b)(6) operated without issues for about 20 minutes before the lifeband (lot#: 197739) unexpectedly tore off.Subsequently, an error message appeared on the platform.The customer mentioned that the display screen's light was defective (dark) but still readable.However, they couldn't recall the error code displayed on the lcd screen.The torn lifeband was contaminated with the patient's bodily fluids and needed to be disposed of.The issue occurred on the way to the destination hospital, and the crew immediately continued manual resuscitation.Resuscitation was briefly interrupted to unload the stretcher from the ambulance.No consequences or impacts on the patient.After the call, the customer attempted to put the autopulse platform back into operation.To do this, they had to remove the remains of the torn lifeband from the shaft.The customer stated that the lifeband had apparently torn on the shaft of the platform, where the band is sewn and glued.The adhesive on the lifeband's black hinged belt guards (skirts) that are threaded into the shaft was no longer in good condition, and the seam could not withstand the strain.Based on the picture provided by the customer, the tyvek liner on the lifeband was completely ripped and separated from the lifeband's hinged belt guards.After replacing the lifeband, the autopulse platform immediately displayed an error code.

• 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: 21867995
• Report Number: 3010617000-2025-00284
• Device Sequence Number: 17323807
• Product Code: DRM
• UDI-Device Identifier: 00849111001588
• UDI-Public: 00849111001588
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/18/2025

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: 8700-0701-08
• Device Lot Number: 197739
• 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: 03/28/2025
• Initial Report FDA Received Date: 04/18/2025
• 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