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

Model Number MODEL 100

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2023

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the autopulse lifeband (lot 165399) would not "click" into position was confirmed during visual inspection.The probable cause for the reported complaint was due to the broken locking tabs on the hinged belt guard.The observed damage appeared to be an isolated instance of an excessive force applied to the hinged belt guards of the lifeband, however, it is unknown when the damage occurred.Upon visual inspection, it was noticed that the autopulse lifeband locking tab was broken off, thus confirming the reported complaint.The locking tab is missing on each of the hinges, so the hinges do not "click" into place.Functional testing of the returned lifeband was performed using a known good autopulse platform.The lifeband could be installed except for the hinges, which did not click into place and dropped out, thus confirming the reported complaint.However, the broken locking tabs do not affect the functionality of the lifeband, and the lifeband was able to perform compressions for 30 minutes on 30:2 mode and for 30 minutes on continuous mode using the manikin without issue.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaints reported for lifeband with lot# 165399.

Event Description

After a call, while the customer was preparing the autopulse platform for the next patient call, the new autopulse lifeband (lot 165399) would not "click" into position.The new lifeband was taken out of the sealed packaging and the customer was able to insert the pin into the drive shaft without issue.But the 2 external clips on the outside that keep the band on would not "click" into position and the band kept falling off as it had nothing holding it in place.The customer replaced the lifeband again.It connected fine and the platform is working as intended.No patient involvement.

• 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 INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17549490
• MDR Text Key: 321165120
• Report Number: 3010617000-2023-00687
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• 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
• Type of Report: Initial
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• 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: 165399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2021
• 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