MAUDE Adverse Event Report: FIAB SPA SENSITHERM MULTI; THERMOMETER, ELECTRONIC, CLINICAL

Model Number ST-PROBE-7

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

Event Date 06/13/2023

Event Type  malfunction  

Event Description

Sensitherm probe utilized at beginning of procedure did not report temperature.Probe removed and new probe obtained.Procedure concluded without harm to patient.

• Brand Name: SENSITHERM MULTI
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): FIAB SPA; 144 research drive hampton; hampton VA 23666
• MDR Report Key: 17441991
• MDR Text Key: 320211327
• Report Number: 17441991
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ST-PROBE-7
• Device Catalogue Number: ST-PROBE-7
• Device Lot Number: 22CB0515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Weight: 87 KG
• Patient Race: White