FDA Adverse Event
Malfunction
Summary report: N
INTELLIVUE
MDR report key: 20619675
·
Received November 6, 2024
Report
- Report Number
- 20619675
- Event Type
- Malfunction
- Date Received
- November 6, 2024
- Date of Event
- February 9, 2024
- Report Date
- September 19, 2024
- Manufacturer
- PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
- Product Code
- MHX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
MULTIPLE ATTEMPTS TO CONNECT SPO2, OR OXYGEN SATURATION, TO TELEMETRY BOX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1418434 | INTELLIVUE | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | MHX | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |