MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS TEMPORAL TEMPERATURE HH; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 989803192931

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2019

Event Type  malfunction  

Event Description

We have exergen thermometers on 3, 7, 9 floors which are integrated with the philips vs4 monitor.There have been several of these items where the display cover has fallen off, exposing the circuit board inside.

• Brand Name: PHILIPS TEMPORAL TEMPERATURE HH
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 9260432
• MDR Text Key: 164461462
• Report Number: 9260432
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 989803192931
• Device Catalogue Number: 989803192931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2019
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1