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

Model Number MODEL 100

Device Problems Material Integrity Problem (2978); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 01/13/2022

Event Type  malfunction  

Event Description

During patient use, customer reported that the autopulse platform (serial (b)(4)) displayed fault code "16" (timeout moving to take-up position) error message.The customer immediately performed manual cpr for the remainder of the event.After the event, the customer noticed the lifeband was twisted in the sleeve and it could not be straighten, and customer decided to cut off the sleeve of the lifeband.Patient's status information was requested but the customer did not provide a response.Please see the following related mfr report: mfr # 3010617000-2022-00111 for the autopulse platform (serial (b)(4)).

Manufacturer Narrative

Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.

Manufacturer Narrative

The reported complaint that "the autopulse lifeband (lot # 170557) had been twisted was confirmed during the visual inspection of the returned lifeband.The probable root cause of the reported complaint was likely incorrectly installed lifeband or the patient displacement/ shift on the platform during the compressions.During the visual inspection, observed the belt on band 1 was twisted, thus confirming the customer's complaint.In general, a twisted belt should not affect the functionality of the lifeband.In addition, both of the protective band sleeves were cut/torn open by the customer, unrelated to the reported complaint.It is possible, the customer wanted to verify the twisted lifeband.Functional testing could not be performed due to the observed damages on 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# 170557.

• 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: 13459386
• MDR Text Key: 285245372
• Report Number: 3010617000-2022-00171
• 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,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• 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: 170557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2021
• 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