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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of damaged autopulse lifeband (lot #182214) was confirmed based on the visual inspection of the returned lifeband and provided pictures.The lifeband shows damage indicative of a twisted belt during use.The hinged belt guard of the lifeband was damaged, likely due to the excessive force applied when the twisted belt was moving through the hinged belt guard opening, likely attributed to user error.The functional testing for the lifeband could not be performed due to the observed damages.The autopulse user guide provides the following caution - make sure that the lifeband is not twisted before automatic compressions begin.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaint reported for lifeband with lot 182214.B3, the date of event is unknown.

Event Description

Per the reporter, the autopulse lifeband (lot # 182214) was damaged.The issue was observed after the use of the autopulse platform (sn (b)(6)) during the patient call.The patient's status information was requested but the customer did not provide a response.B3, the date of event is unknown.

• 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; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 19102786
• MDR Text Key: 340184774
• Report Number: 3010617000-2024-00309
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/13/2024

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
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0701-01
• Device Lot Number: 182214
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2022
• 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