• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES ALLON THERMAL REGULATING SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BELMONT MEDICAL TECHNOLOGIES ALLON THERMAL REGULATING SYSTEM Back to Search Results
Model Number ALLON 2001
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The allon has not been returned to belmont for evaluation. We have reached out to the distributor to request that the unit be returned for investigation. The operator's manual provides a detailed troubleshooting guide, including potential causes of a problem and the action to be taken. Without additional information, it is difficult to determine what occurred in this case at this time. We will continue to follow up with the distributor to obtain additional details about the case. No patient injury was reported. Should additional information become available, a supplemental report will be submitted.
 
Event Description
The user facility reported that there was no water flow while using the allon.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameALLON
Type of DeviceTHERMAL 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 Key10019824
MDR Text Key189697944
Report Number1219702-2020-00036
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier07290107581103
UDI-Public07290107581103
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K024128
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberALLON 2001
Device Catalogue Number100-00001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/08/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-