FDA Adverse Event
Malfunction
Summary report: N
TEMPUS PRO
MDR report key: 18991709
·
Received March 28, 2024
Report
- Report Number
- 3003832357-2024-00272
- Event Type
- Malfunction
- Date Received
- March 28, 2024
- Date of Event
- March 15, 2024
- Report Date
- October 16, 2024
- Manufacturer
- RESPIRATORY TECHNOLOGIES, INC.
- Product Code
- MHX
- UDI-DI
- 05060472440013
- PMA / PMN Number
- K201746
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LU
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT THE DEVICE FAILS TO BOOT UP. NO PATIENT HARM OR INJURY HAS BEEN REPORTED. FURTHER INFORMATION WILL BE SEND UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 911106 | TEMPUS PRO | MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS) | MHX | RESPIRATORY TECHNOLOGIES, INC. | 00-1007-R | 05060472440013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |