FDA Adverse Event
Injury
Summary report: N
TEMPUS PRO
MDR report key: 16744005
·
Received April 14, 2023
Report
- Report Number
- 3003832357-2023-00221
- Event Type
- Injury
- Date Received
- April 14, 2023
- Date of Event
- April 4, 2023
- Manufacturer
- REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
- Product Code
- MHX
- UDI-DI
- 05060472441027
- PMA / PMN Number
- K201746
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
DEVICE PROBLEM CODE GRID AND HEALTH IMPACT GRID UPDATE.
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT TEMPUS PRO EXPERIENCED AN ISSUE WHERE NO RHYTHM WAS SEEN DURING USE. ALTHOUGH NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED, WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY DUE TO A SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT BECAUSE LIVE-SAVING THERAPY/TREATMENT MAY HAVE BEEN INTERRUPTED/DELAYED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 387325 | TEMPUS PRO | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | MHX | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. | 00-1024-R | 05060472441027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Life Threatening |