MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES CRITICOOL; THERMAL REGULATING SYSTEM

Model Number INFANT CUREWRAP

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The wrap has not been returned to belmont for evaluation.We have reached out to the user facility to obtain additional information about the case, and to determine whether the wrap is available to be returned for investigation.The operator's manual provides the following warning: "do not lift or move the patient by means of the wrap.This may cause tearing and water leakage from the wrap." the following precaution is also provided: "if moisture or leaks are discovered in the connecting hose and/or wrap, turn off the criticool device, disconnect the power cable from its power source, and correct the problem before proceeding." without additional information, it is difficult to determine what occurred during the case at this time.Should additional information become available, a supplemental report will be submitted.

Event Description

The user facility reported that an infant curewrap was leaking.

Manufacturer Narrative

The incident occurred three months prior to being reported, therefore the wrap in question was not available for investigation and the reported leak could not be confirmed.A sample of two infant curewraps were removed from production and tested on a criticool system for approximately two hours; no leaks were observed.A review of the manufacturing and leak test records for this lot number indicated no deviations or anomalies.All curewraps are 100% leak tested by the manufacturer prior to being released for shipment.The operator's manual provides the following warning: "do not lift or move the patient by means of the wrap.This may cause tearing and water leakage from the wrap." the following precaution is also provided: "if moisture or leaks are discovered in the connecting hose and/or wrap, turn off the criticool device, disconnect the power cable from its power source, and correct the problem before proceeding." no report of patient harm.Belmont will continue to monitor and trend similar reports of this nature.

• Brand Name: CRITICOOL
• Type of Device: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica, ma
• Manufacturer Contact: sabrina belladue ; 780 boston road; billerica, ma ; 3307637
• MDR Report Key: 10048414
• MDR Text Key: 198523374
• Report Number: 1219702-2020-00038
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 07290012127199
• UDI-Public: 07290012127199
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083662
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INFANT CUREWRAP
• Device Catalogue Number: 500-03521
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1