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

Model Number MODEL 100

Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Event Description

During shift check, the customer installed lifeband#1 (lot #161862) to test the autopulse platform (sn (b)(4)).After performing a few compressions, the autopulse platform stopped working with an unusual sound and displayed an unknown error message.The customer observed that the fabric holding the lifeband band clip was torn, and the band clip was detached.The customer replaced it with another lifeband #2 (lot #161862) and restarted the platform.Shortly after compression, the hinged belt guard on lifeband got broken with an unusual sound.After the reported issue, the customer tested the autopulse platform with another lifeband, and the platform functioned as intended.No patient involvement.Please see the following related mfr report: mfr 3010617000-2022-00104 for the autopulse platform (sn (b)(4)) mfr 3010617000-2022-00106 for the lifeband #2 (lot #161862).

Manufacturer Narrative

The customer reported that "the fabric holding the lifeband (lot #161862) band clip was torn, and the band clip was detached" was confirmed during the visual inspection.The root cause for the reported damage was due to a missing patch attached to the belt clip.The patch protects the long belt against the friction generated during the rotation into the platform shaft, likely attributed to the isolated incident during the lifeband assembly.No previous reports of assembly error.Upon visual inspection, it was observed that the stitches on the belt near the belt clip were separated and the band clip completely detached with no presence of the patch attached to the clip.Functional testing could not be performed due to the observed lifeband damage.Historical complaints were reviewed for information related to the reported complaint, and there was no similar complaint reported for lifeband with lot# 161862.

• 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: 13502664
• MDR Text Key: 285702151
• Report Number: 3010617000-2022-00105
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065016
• UDI-Public: 00849111065016
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/09/2022

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
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0701-03
• Device Lot Number: 161862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2022
• Initial Date FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2021
• 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