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

Catalog Number 200-00263

Device Problem No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Manufacturer Narrative

As of the date of this report the allon involved in the incident has not been returned to belmont for investigation, therefore we are unable to confirm that the system is constantly alarming as reported.As the initial reporter was unable to identify the specific alarms exhibited by the system, there is insufficient information to determine a potential root cause at this time.The manufacturing records for this serial number were reviewed and no anomalies were identified.The hospital has stated that the unit will be returned to belmont for evaluation.The unit will be investigated upon receipt and a follow-up report will be submitted accordingly.

Event Description

The hospital biomed reported that the allon was constantly alarming but was unable to identify the specific alarms that the system was exhibiting.

• Brand Name: ALLON
• Type of Device: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: sabrina belladue ; 780 boston road; billerica, MA 01821 ; 9783307637
• MDR Report Key: 12139621
• MDR Text Key: 267828497
• Report Number: 1219702-2021-00089
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 07290107581103
• UDI-Public: 7290107581103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/08/2021

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 Catalogue Number: 200-00263
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1