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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Per a reporter, the lifeband 3 pack had an unknown issue during the call.The issue was noted within a few minutes after the platform started compressions.Another platform was utilized, however, a similar issue occurred two more times.No additional information was provided.The patient's status information was requested but the customer did not provide a response, therefore the patient's status 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: kim nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 11086054
• MDR Text Key: 227070279
• Report Number: 3010617000-2020-01319
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 10849111001691
• UDI-Public: 10849111001691
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2020

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: 8700-0706-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/29/2020
• 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