FDA Adverse Event
Malfunction
Summary report: N
TELETOM 363
MDR report key: 381374
·
Received February 25, 2002
Report
- Report Number
- 1220685-2002-00001
- Event Type
- Malfunction
- Date Received
- February 25, 2002
- Date of Event
- January 7, 2002
- Report Date
- February 21, 2002
- Manufacturer
- BERCHTOLD CORP.
- Product Code
- KMI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A MONITOR POSITIONED ON A TELETOM 363 POWER BOOM FELL OFF THE TOP SHELF OF THE BOOM STRIKING A PT IN THE PELVIC REGION. THE BOOM WAS SAID TO BE LEARNING SLIGHTLY AT A DOWNWARD ANGLE WHEN A NURSE REPOSITIONED THE BOOM WHICH LED TO THE MONITOR TILTING FORWARD AND FALLING OFF THE BOOM AND STRIKING THE PT CAUSING BRUISING TO THE PELVIC REGION. THE MONITOR IS NORMALLY STRAPPED TO THE SHELF, BUT THE STRAP HAD BEEN REMOVED BY HOSP PERSONNEL CLEANING THE ROOM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELETOM 363 | POWER BOOM | KMI | BERCHTOLD CORP. | 363 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other |