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

Model Number	MODEL 100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.
Event or Problem Description
The customer reported that the autopulse lifeband (lot #158870) does not clip to the autopulse platform.Out of the three lifeband received, two are functional.No patient involvement.
Additional Manufacturer Narrative
The report of the autopulse lifeband (lot # 158870) will not clip into the autopulse platform was confirmed during the visual inspection.The probable cause for the reported complaint was due to the loose locking tabs on both sides of the hinged belt guards that do not produce a clicking sound.The observed damage appeared to be an isolated instance of an excessive force applied to the hinged belt guards of the lifeband, however, it is unknown when the damage occurred.Upon visual inspection, it was noticed that both sides of the autopulse lifeband locking tabs were loose and not allowing the hinged belt guard to lock in place when moved to the flip-down position, thus confirming the reported complaint.Functional testing was not performed as 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 complaint reported for lifeband with lot #158870.

• 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 nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 12670738
• Report Number: 3010617000-2021-01012
• Device Sequence Number: 17183961
• Product Code: DRM
• UDI-Device Identifier: 10849111001691
• UDI-Public: 10849111001691
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2022

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0706-01
• Device Lot Number: 158870
• 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: 09/23/2021
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2021
• 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