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

Model Number	100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that the belt guards on the side of the autopulse lifeband (lot# 181831) came unlocked and would not click back was not confirmed during the visual inspection and functional testing of the returned lifeband.During testing, no device malfunction was found, and the lifeband functioned appropriately and as intended.Functional testing of the returned lifeband was performed using a known good autopulse platform and the platform owned by the customer.The installation test was successful.The lifeband clip and belt guide locking tabs locked correctly, and the hinged belt guides snapped into position properly.The platform passed a 30-minute test on a normal manikin, with all lifeband parts functioning correctly.
Event or Problem Description
During the call, the staff member was informed that the belt guards on the side of the autopulse lifeband (lot# 181831) came unlocked and would not click back.The crew has decided to remove the device and replace it with lucas to perform compressions.No consequences or impact to the patient.When the platform was removed from the patient, the black cover plate of the lifeband came loose, however, the lifeband belt clip was still in the slot of the drive shaft.After the call, the staff member changed the lifeband and did not see any errors on the device.The device was tested over the weekend and confirmed to be functional.

• 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
• MDR Report Key: 19768131
• Report Number: 3010617000-2024-00555
• Device Sequence Number: 12890250
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/17/2024

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: 181831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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