MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. ZOLL START-UP KIT CUSTOM LUER; SYSTEM, HYPOTHERMIA, INTRAVENOUS, COOLING

Model Number CG-500D

Device Problem Material Separation (1562)

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

Event Date 05/04/2023

Event Type  malfunction  

Event Description

Disconnecting set up from line.Set up came apart at distal end.

• Brand Name: ZOLL START-UP KIT CUSTOM LUER
• Type of Device: SYSTEM, HYPOTHERMIA, INTRAVENOUS, COOLING
• Manufacturer (Section D): ZOLL CIRCULATION, INC.; 269 mill road; chelmsford MA 01824
• MDR Report Key: 16960850
• MDR Text Key: 315548203
• Report Number: 16960850
• Device Sequence Number: 1
• Product Code: NCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CG-500D
• Device Catalogue Number: 8700-0784-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9490 DA
• Patient Sex: Male