MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. LIFEBAND® LOAD-DISTRIBUTING BAND; CARDIAC RESUSCITATOR BAND

Model Number	100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received autopulse lifeband for investigation.A supplemental report will be filed when the product is returned, and investigation has been completed.
Event or Problem Description
During a patient call, the autopulse lifeband (lot# unknown) did not retract to size the patient, and hinged belt guards failed to secure it to the autopulse platform (sn (b)(6).The area on the back of the platform, where the lifeband is attached, was observed to have physical damage and the lifeband could not snap securely to the autopulse platform.In addition, the lifeband twisted during the sizing of the patient.The platform worked for two minutes; however, it stopped without displaying any error messages.The patient's status information was requested but the customer did not provide a response.
Additional Manufacturer Narrative
The reported complaint of the autopulse lifeband (lot# 184028) hinged belt guards failed to secure it to the autopulse platform was confirmed during a visual inspection of the returned lifeband.Both of the hinged belt guards (skirts) were noted to be broken.This issue prevented the hinged belt guards from being snapped in place, confirming the reported complaint.The observed damage appeared to be an isolated instance of excessive force applied to the hinged belt guards during the placement of the lifeband.The customer reported issue of the lifeband being twisted during the sizing of the patient was not confirmed during the visual inspection and functional testing.Functional testing of the returned lifeband was performed using a known good autopulse platform.The lifeband could be installed except for the hinged belt guards, which did not click into place, thus confirming the reported complaint.However, the observed damages do not affect the functionality of the lifeband, and the lifeband was able to perform compressions using the manikin without issue.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 184028.Additional information: b5- describe event or problem, d4- lifeband lot#.Correction: h6- health effect - clinical code and impact code.
Event or Problem Description
During a patient call, the autopulse lifeband (lot# 184028) did not retract to size the patient, and hinged belt guards failed to secure it to the autopulse platform sn (b)(6).The area on the back of the platform, where the lifeband is attached, was observed to have physical damage and the lifeband could not snap securely to the autopulse platform.In addition, the lifeband twisted during the sizing of the patient.The platform worked for two minutes, however, it stopped without displaying any error messages.The crew switched to manual cpr.There were no consequences or impacts on the patient.

• Brand Name: LIFEBAND® LOAD-DISTRIBUTING BAND
• Common Device Name: CARDIAC RESUSCITATOR BAND
• Manufacturer (Section D): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 19978355
• Report Number: 3010617000-2024-00690
• Device Sequence Number: 2760391
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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
• Operator of Device: Health Professional
• Device Model Number: 100
• Device Catalogue Number: 8700-0701-01
• Device Lot Number: 184028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown