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	Insufficient Information (4580)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device associated with this complaint has been received, however, the investigation is pending.A follow-up report will be filed when the investigation has been completed.
Event or Problem Description
During the patient call, the autopulse platform (sn (b)(6)) was unable to retract the lifeband and displayed a user advisory 34 (communication fault with position encoder) error message.The platform battery was reinstalled and the device was powered on normally.The lifeband (lot# unknown) was pulled up and placed on the patient, however, when the platform initiated the retraction, the lifeband snapped.The patient's status information was requested but the customer did not provide a response.
Additional Manufacturer Narrative
The reported complaint of lifeband (lot #180813) had snapped was confirmed during the visual inspection.The distant end of the lifeband belt was observed to be completely detached.Upon visual inspection, observed that the stitches on one side of the band were missing, and as a result, the band got detached.Functional testing could not be performed due to the lifeband condition.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaints reported for lifeband with lot# 180813.Additional information lifeband lot#, b5, d4.
Event or Problem Description
During the patient call, the autopulse platform (sn (b)(6)) would not tighten the lifeband and displayed a user advisory 34 (communication fault with position encoder) error message.The platform battery was reinstalled and the device was powered on normally.The lifeband (lot# 180813) was pulled up and placed on the patient, however, when the platform initiated the compression, the lifeband snapped.The patient's status information was requested but the customer did not provide a response.

• 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: 19788294
• Report Number: 3010617000-2024-00567
• Device Sequence Number: 20707021
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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: 180813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 07/21/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2022
• 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