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

Model Number	100
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During shift check, one of the hinged belt guards of the lifeband (lot 173316) had some issues and was unable to engage to the roller.No patient involvement.
Additional Manufacturer Narrative
Zoll has not received the lifeband for investigation.A follow-up report will be submitted when the product is returned, and the investigation has been completed.
Additional Manufacturer Narrative
The reported complaint that one of the hinged belt guards of the lifeband (lot 173316) had some issues and was unable to engage to the roller was confirmed during the visual inspection.The hinged belt guard on one side was loose, as the locking pin was pushed away from the body of the lifeband cover plate, likely due to the lifeband storage conditions by the user.Upon further visual inspection, no other physical damage was observed on the lifeband.Functional testing was not performed, as the locking tabs do not affect the functionality of the lifeband.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaints reported for lifeband with lot 173316.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: LIFEBAND® LOAD-DISTRIBUTING BAND
• Common Device Name: CARDIAC RESUSCITATOR BAND
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17941177
• Report Number: 3010617000-2023-00906
• Device Sequence Number: 6416395
• Product Code: DRM
• UDI-Device Identifier: 10849111002247
• UDI-Public: 10849111002247
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2024

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: 8700-0706-14
• Device Lot Number: 173316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 10/25/2023; 07/22/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 10/27/2023; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2022
• 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