FDA Adverse Event
Malfunction
Summary report: N
TEMPUS PRO
MDR report key: 19982391
·
Received August 14, 2024
Report
- Report Number
- 3003832357-2024-00610
- Event Type
- Malfunction
- Date Received
- August 14, 2024
- Date of Event
- August 12, 2024
- Report Date
- November 18, 2025
- Manufacturer
- REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
- Product Code
- MHX
- PMA / PMN Number
- K201746
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
IT HAS BEEN REPORTED TO PHILIPS THE ACCESSORY HAS AN INCORRECT PRODUCT DESCRIPTION FOR 01-2183 IT DESCRIBED AS A "TEMPUS PRO 6-LEAD ECG LIMB LEADS FOR MODULAR CABLE (IEC), UNIVERSAL," BUT IT IS A TEMPUS PRO 6-LEAD ECG CHEST LEADS FOR MODULAR CABLE (IEC), UNIVERSAL,".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 560834 | TEMPUS PRO | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. | MHX | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. | 01-2072 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |