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

Model Number MODEL 100

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the broken autopulse lifeband (lot # 189280) band clip was confirmed during the visual inspection of the returned lifeband.Noticed a broken head end of the lifeband belt clip.The observed damage appeared to be an isolated instance of excessive force applied to the lifeband belt.During the visual inspection observed returned lifeband with the band clip completely cut off from the lifeband with the head end of the lifeband belt clip detached, thus confirming the reported complaint.In addition, during the visual inspection, unrelated to the reported complaint, it was also noted that the protective cloth cover (tyvek liner) was completely detached from the hinged belt guards on both sides of the lifeband bands by being forcibly ripped from its fixing points.The observed damage was most likely caused by force applied to the band during compressions, as both lifeband bands were observed to be twisted.Functional testing could not be performed due to the observed damage to the returned 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# 189280.

Event Description

During patient use, the lifeband (lot # 189280) band clip broke off, preventing it from being secured into the driveshaft slot of the autopulse platform.The crew reverted to manual cpr for the rest of the call.The patient's status information was requested, but the customer did not provide a response.

• 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18509183
• MDR Text Key: 333231261
• Report Number: 3010617000-2024-00028
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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: 189280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1