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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Fitting Problem (2183)

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

Event Date 12/23/2021

Event Type  malfunction  

Event Description

The autopulse platform (sn unknown) was used to resuscitate a patient in cardiac arrest.The user installed the new lifeband (lot# unknown) to use with the platform, however, the platform could not make compressions.The crew reverted to manual cpr for the rest of the call.No consequences or impact to the patient.Upon returning to the ems center, the crew noticed that the lifeband band clip that snaps into the autopulse platform was broken.Please see the following related mfr report: mfr #3010617000-2022-00317 for the autopulse platform.

Manufacturer Narrative

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

Event Description

The autopulse platform (sn unknown) was used to resuscitate a patient in cardiac arrest.The user installed the new lifeband (lot# 86646) to use with the platform, however, the platform could not make compressions.The crew reverted to manual cpr for the rest of the call.No consequences or impact to the patient.Upon returning to the ems center, the crew noticed that the lifeband band clip that snaps into the autopulse platform was broken.

Manufacturer Narrative

The reported complaint of "the platform could not make compressions after the user installed the new lifeband (lot# 86646)" was confirmed during the visual inspection.Noticed a broken head end of the lifeband belt clip.The probable root cause for the broken lifeband was a potential degradation of the material due to storage conditions or mishandling.The lifeband was manufactured in august 2018 and was shipped to the customer between august and november 2018.The storage condition of the lifeband for the past 4 years is unknown.In addition, during the visual inspection, unrelated to the reported complaint, noticed one side of the autopulse lifeband locking tab was loose and not allowing the hinged belt guard to lock in place when moved to the flip-down position.The locking tabs do not affect the functionality of the lifeband.Functional testing could not be performed due to the broken belt clip.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for lifeband lot number 86646.

• 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: 13749185
• MDR Text Key: 287551534
• Report Number: 3010617000-2022-00249
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

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: 8700-0701-01
• Device Lot Number: 86646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 03/12/2022
• Supplement Dates Manufacturer Received: 06/30/2022
• Supplement Dates FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2018
• 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