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

Model Number	MODEL 100
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that "one of the hinged belt guards of the lifeband (lot # 168928) broke apart" was confirmed during the visual inspection of the returned lifeband.One side of one of the hinged belt guards was broken.The observed damage appeared to be an isolated instance of excessive force applied to the hinged belt guard of the lifeband.Upon visual inspection, it was also noted that the protective cloth cover (tyvek liner) was completely detached from the broken hinged belt guard, by being forcibly ripped from its fixing points.The customer did not mention the torn tyvek liner on the same side as the broken hinged belt guard, but it was also most likely caused by force applied to the band when it was pulled up.Furthermore, one of the locking tabs and the belt cover pin on the belt cover were observed broken, unrelated to the reported complaint.Such physical damage to the belt cover pin suggests that a force was applied on that particular side of the lifeband belt cover.Also, the fabric of the band was torn, likely due to excessive force applied to the hinged belt guards of the lifeband.Functional testing could not be performed due to the observed lifeband damage.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
During patient use, one of the hinged belt guards (skirts) of the lifeband (lot # 168928) broke apart.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: 16881627
• Report Number: 3010617000-2023-00426
• Device Sequence Number: 7261868
• Product Code: DRM
• UDI-Device Identifier: 00849111001601
• UDI-Public: 00849111001601
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2023

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
• Date Returned to Manufacturer: 04/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 05/05/2023
• 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