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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the lifeband in complaint for investigation.A follow-up report will be submitted if and when the product is returned, and an investigation has been completed.

Event Description

The autopulse lifeband (lot # 178103) was used along with an autopulse platform to resuscitate a patient in cardiac arrest.The customer reported that on its initial tightening (take-up) of the lifeband around the patient's chest, the band (polyester belt) was twisted inside the outer sheath (tyvek liner) of the lifeband.The customer untwisted and straightened the band and properly positioned the lifeband on the patient's chest.Then, the customer tried another take-up of the lifeband but stated that the lifeband became jammed and acted as if the internal strap broke, which prevented the customer from pulling up the lifeband to reset it.The customer provided pictures showing that the outer tyvek sleeve was being pulled through the opening slot of the lifeband hinged belt guard (skirt).The crew switched to manual cpr until another platform was put in place.No consequences or impacts on the patient.After the call, the customer tested the first autopulse platform with another lifeband, and the platform functioned as intended.

Manufacturer Narrative

D9 (returned to manufacturer) was added.H4 (device manufacture date) was added.H6 codes were updated.The reported complaint that "the autopulse lifeband (lot #178103) became jammed" was confirmed during the visual inspection of the returned lifeband.The evaluation of the lifeband showed damage indicative of a twisted band during use, likely attributed to user mishandling.During the visual inspection, it was observed that the protective cloth (tyvek liner) had been dragged into the hinged belt guards.This interference with the hinged belt guards prevented the lifeband band from moving as intended.To investigate further, the tyvek liner was cut open, revealing that the lifeband was twisted two times inside it.This twist prevented the initial tightening of the lifeband during take-up, and thus, the platform could not initiate compressions.Functional testing could not be performed due to the observed damage 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#178103.

• 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: 16616470
• MDR Text Key: 312216710
• Report Number: 3010617000-2023-00294
• 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: 07/19/2023

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: 8700-0701-01
• Device Lot Number: 178103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 06/26/2023
• Supplement Dates FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2022
• 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