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 10/17/2022

Event Type  malfunction  

Event Description

During patient use, the lifeband band clip had broken off and preventing the hinged belt guard of the lifeband (lot #unknown) from snapping in place to the autopulse platform.The autopulse platform (b)(6) displayed user advisory "(ua)12" (lifeband not present) error message.The customer performed 20-30 manual cpr and rosc was achieved at the hospital.Back at the station, a new lifeband (lot #175571) was also noticed with the same issue while just snapping the band clip off and on.The lifeband used on a patient was disposed and the lifeband used at the station was returned for evaluation.No consequences or impact to the patient.Please see the following related mfr report: mfr 3010617000-2022-01952 for the autopulse platform (b)(6).Mfr 3010617000-2022-02013 for the lifeband (lot #unknown).

Manufacturer Narrative

The report of the autopulse lifeband (lot # 175571) will not clip into the autopulse platform was confirmed during the visual inspection.The probable cause for the reported complaint was the broken locking tabs on the hinged belt guards of the lifeband.The observed damage appeared to be an isolated instance of excessive force applied to the hinged belt guards of the lifeband.In addition, during the visual inspection, unrelated to the reported complaint, noticed the autopulse lifeband head end of the band clip was missing.The missing piece was located inside the platform driveshaft likely as a result of user mishandling.The broken piece of the band clip was removed to allow the placement of the lifeband on the platform.Functional testing could not be performed due to the broken band clip.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for the lifeband lot number 175571.

• 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 ; 4085411030
• MDR Report Key: 16933832
• MDR Text Key: 315531707
• Report Number: 3010617000-2022-01949
• 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
• Report Date: 11/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• 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: 175571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2022
• 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