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

Model Number MODEL 100

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 01/09/2024

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 335332309
• Report Number: 3010617000-2024-00140
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1