FDA Adverse Event
Malfunction
Summary report: N
TEMPUS PRO
MDR report key: 20278379
·
Received September 23, 2024
Report
- Report Number
- 3003832357-2024-00698
- Event Type
- Malfunction
- Date Received
- September 23, 2024
- Date of Event
- September 17, 2024
- Report Date
- December 16, 2024
- Manufacturer
- REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
- Product Code
- MHX
- PMA / PMN Number
- K201746
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
UPDATED COMPONENT CODE AND CONCLUSION CODE.
Additional Manufacturer Narrative · 0
UPDATED HEALTH IMPACT CODE - NO HEALTH CONSEQUENCES.
Additional Manufacturer Narrative · 0
UPDATED HEALTH IMPACT CODE - NO HEALTH CONSEQUENCES.
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT NOT ABLE TO SEND THE RECORD FOR MORE THAN 2 HOURS DURING THE TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1671831 | TEMPUS PRO | MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS) | MHX | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. | 00-1024-R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |