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

Model Number	MODEL 100
Medical Device Problem Codes	Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that during the strenuous effort to position the patient on the x-ray table, the lifeband (lot # unknown) broke apart.The customer sent pictures showing that one of the hinged guards of the lifeband cover plate was broken.The tyvek liner was ripped, and the band was jammed and twisted.While installing the second lifeband (lot # unknown), the band locking clip broke.The customer continued the resuscitation attempt with manual cpr.No consequences or impacts on the patient.Please see the following related mfr report: mfr # 3010617000-2023-00397 for the first lifeband.
Additional Manufacturer Narrative
The reported complaint of "broken band locking clip" was confirmed during visual inspection of the returned lifeband (lot # 168928).One side of the lifeband locking tabs was observed loose as the locking pin was pushed away from the body of the lifeband cover plate, likely attributed to the lifeband storage conditions by the user.No other physical damage was observed on the lifeband.Functional testing was not performed, as the locking tabs do not affect the functionality of the 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# 168928.
Event or Problem Description
The customer reported that during the strenuous effort to position the patient on the x-ray table, the lifeband (lot # 168928) broke apart.The customer sent pictures showing that one of the hinged guards of the lifeband cover plate was broken, the tyvek liner was ripped, and the band was jammed and twisted.While installing the second lifeband (lot # 168928), the band locking clip broke.The customer continued the resuscitation attempt with manual cpr.No consequences or impacts on the patient.

• Brand Name: AUTOPULSE® LIFEBAND
• Common Device Name: 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: 16766092
• Report Number: 3010617000-2023-00411
• Device Sequence Number: 6105661
• Product Code: DRM
• UDI-Device Identifier: 10849111001691
• UDI-Public: 10849111001691
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 05/11/2023

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0701-16
• Device Lot Number: 168928
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• 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