FDA Adverse Event
Malfunction
Summary report: N
DINAMAP CARESCAPE
MDR report key: 15612118
·
Received October 14, 2022
Report
- Report Number
- 15612118
- Event Type
- Malfunction
- Date Received
- October 14, 2022
- Date of Event
- September 21, 2022
- Report Date
- September 21, 2022
- Manufacturer
- GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
- Product Code
- MWI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NY
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
A/C CONNECTOR ¿ ON GE DINAMAP CARESCAPE V100 VITAL SIGNS MONITOR ¿ BROKE AND BUTTONS NOT REGISTERING COMMANDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2821441 | DINAMAP CARESCAPE | MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) | MWI | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | V100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |