FDA Adverse Event
Other
Summary report: N
DELTA
MDR report key: 730125
·
Received June 23, 2005
Report
- Report Number
- 1220063-2005-00011
- Event Type
- Other
- Date Received
- June 23, 2005
- Date of Event
- May 26, 2005
- Report Date
- May 26, 2005
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC.
- Product Code
- DSI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED INCIDENT IS UNDER INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPROTED A DELTA BEDSIDE PT MONITOR AND IV POLE MONITOR MOUNT BECAME SEPERATED FROM THE IV POLE IT WAS CONNECTED TO. THE PT MONITOR AND MOUNT FELL ONTO A TABLE. THE IV POLE SHOWED VISUAL INTENTS, WHERE THE MOUNTING CLAMP WAS SECURED. NO PT OR USER INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTA | BEDSIDE PT MONITOR | DSI | DRAEGER MEDICAL SYSTEMS, INC. | MS13464 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | MONITOR DOCKING STATION IV POLE MOUNT |