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

Model Number MODEL 100

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 10/29/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The autopulse platform (sn (b)(4)) displayed user advisory (ua) 02 (compression tracking error) during the resuscitation of a cardiac arrest patient.Immediately, the crew reverted to manual cpr for the rest of the call.After the patient event, the customer checked the lifeband (lot #unknown), and it was twisted.The customer tested the platform with a manikin, and the ua02 message was not reproduced.The patient's status information was requested, but the customer did not provide a response.Please see the following related mfr report: mfr 3010617000-2022-01987 for the autopulse platform sn (b)(4).

• 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: kim nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 15853448
• MDR Text Key: 304206982
• Report Number: 3010617000-2022-02036
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/23/2022

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
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0701-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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