FDA Adverse Event
Malfunction
Summary report: N
DELTA
MDR report key: 1952701
·
Received January 4, 2011
Report
- Report Number
- 1220063-2010-00099
- Event Type
- Malfunction
- Date Received
- January 4, 2011
- Date of Event
- November 30, 2010
- Report Date
- November 30, 2010
- Manufacturer
- DRAGER MEDICAL SYSTEMS, INC. (IT/M)
- Product Code
- MHX
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A F/U REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE MONITOR DID NOT GENERATE VT ALARM WHEN EXPECTED. FUNCTIONAL TESTING OF THE MONITOR IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE WAS "O.K.". THERE WAS NO PT INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTA | PATIENT MONITOR | MHX | DRAGER MEDICAL SYSTEMS, INC. (IT/M) | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | NO |