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

Model Number MODEL 100

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2022

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the life band for investigation.A follow-up report will be submitted when the product is returned, and the investigation has been completed.

Event Description

Upon receiving the autopulse life band(lot# unknown), the customer reported it will not clip into the autopulse platform.No patient involvement.

Manufacturer Narrative

D4 (additional device information) was corrected.The report of the autopulse lifeband (lot # 160917) will not clip into the autopulse platform was confirmed during the visual inspection.The probable cause for the reported complaint was due to the broken locking tab on the hinged belt guard of the lifeband.The observed damage was appeared to be an isolated instance of an excessive force applied to the hinged belt guard of the lifeband, however, it is unknown when the damage occurred.Upon visual inspection, the autopulse lifeband locking tab was broken off, preventing the hinged belt guard of the lifeband from snapping in place, thus confirming the reported complaint.Functional testing was not performed due to the observed physical 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 # 160917.

• Brand Name: AUTOPULSE® LIFEBAND
• Type of Device: CARDIAC RESUSCITATOR BAND
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 13595093
• MDR Text Key: 286858026
• Report Number: 3010617000-2022-00158
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0701-01
• Device Lot Number: 160917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1