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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that "the hinged belt guard on lifeband (lot #161862) got broken" was confirmed during the visual inspection.The probable cause for the physical damage was appeared to be characteristics of a harsh impact due to mishandling.Upon visual inspection, it was observed that the autopulse lifeband hinged belt guard was broken off into two pieces, thus confirming the reported complaint.It is possible that the lifeband hinged belt guard was not flipped down and snapped into place fully before the platform was turned over and placed on the ground.Functional testing could not be performed due to the observed damage on the lifeband.Historical complaints were reviewed for information related to the reported complaint, and there was no similar complaint reported for lifeband with lot# 161862.
Event or Problem Description
During shift check, the customer installed lifeband#1 (lot #161862) to test the autopulse platform (sn (b)(4)).After performing a few compressions, the autopulse platform stopped working with an unusual sound and displayed an unknown error message.The customer observed that the fabric holding the lifeband band clip was torn, and the band clip was detached.The customer replaced it with another lifeband #2 (lot #161862) and restarted the platform.Shortly after compression, the hinged belt guard on lifeband got broken with an unusual sound.After the reported issue, the customer tested the autopulse platform with another lifeband, and the platform functioned as intended.No patient involvement.Please see the following related mfr report: mfr 3010617000-2022-00104 for the autopulse platform (sn (b)(4)).Mfr 3010617000-2022-00105 for the lifeband #1 (lot #161862).

• 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: 13502665
• Report Number: 3010617000-2022-00106
• Device Sequence Number: 5387952
• Product Code: DRM
• UDI-Device Identifier: 00849111065016
• UDI-Public: 00849111065016
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/09/2022

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: 8700-0701-03
• Device Lot Number: 161862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2021
• 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