MalfunctionBYT
NEV100
Received Apr 8, 2004 · Event occurred Mar 9, 2004
Report 2518422-2004-00027 · MDR key 548635
Device
Generic name
Negative Pressure External Ventilator
Manufacturer
Respironics, Inc.Model number
12001Catalog number
12001
Lot number
NA
Product problems
- No Audible Alarm
- Loose
- Repair
Patient
NA
Narrative
Description of Event or Problem
THE UNIT WAS RETURNED FOR PREVENTATIVE MAINTENANCE WITH NO PROBLEMS IDENTIFIED. THE UNIT HAD NOT BEEN SERVICED BY RESPIRONICS SINCE 2000. DURING THE REPAIR EVAL IT WAS DISCOVERED THAT THE UNIT'S AUDIBLE ALARM WAS NOT FUNCTIONING. THE DISPLAY AND POWER BOARDS HAD BECOME LOOSE AND WERE RESEATED TO CORRECT THE PROBLEM. THERE WAS NO PT INVOLVEMENT OR REPORTED HARM.
Remedial action
- Other