MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LIFEBAND; CARDIAC RESUSCITATOR BAND

Model Number	MODEL 100
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer initially reported that the autopulse platform sn (b)(6) had broken during patient use.Based on the additional information received, the lifeband (lot #158508) had broken during patient use, and the autopulse platform used during the event functions as intended.No further information was provided.The patient's status information was requested, but the customer did not provide a response.
Additional Manufacturer Narrative
The customer's reported complaint that the lifeband (lot #158508) had broken during the compressions was confirmed during the visual inspection of the returned lifeband.The visual inspection of the returned lifeband revealed that the lifeband band got torn and detached from the hinged belt guards, and multiple tears on the tyvek liner and lifeband band were noted.The root cause of the damage was not conclusively determined; however, an excessive force applied to the belt can result in such damage.Therefore, user mishandling cannot be ruled out.The functional testing for the lifeband could not be performed due to the observed damages.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the lifeband with lot #158508.

• Brand Name: AUTOPULSE® LIFEBAND
• Common Device Name: CARDIAC RESUSCITATOR BAND
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18699773
• Report Number: 3010617000-2024-00140
• Device Sequence Number: 7352474
• 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): 02/13/2024

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: MODEL 100
• Device Catalogue Number: 8700-0701-01
• Device Lot Number: 158508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2021
• 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