FDA Adverse Event
Malfunction
Summary report: N
KAPPA XLT
MDR report key: 961544
·
Received December 6, 2007
Report
- Report Number
- 1220063-2007-00040
- Event Type
- Malfunction
- Date Received
- December 6, 2007
- Date of Event
- October 10, 2007
- Report Date
- December 5, 2007
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC.
- Product Code
- MHX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT IS CURRENTLY UNDER INVESTIGATION. ADD'L SERIAL NUMBERS: (B)(4), ADD'L DEVICE MFR DATE: (B)(4) 2006.
Description of Event or Problem · 1
DRAEGER MEDICAL SYSTEMS, INC. HAS RECEIVED INFO FROM A CUSTOMER THAT STARTING ON (B)(6) 2007, SEVEN OF OUR KAPPA XLT MONITORS RESTARTED DURING NORMAL OPERATION ONE BY ONE. THIS PROBLEM OCCURRED MANY TIMES. SOMETIMES IT TAKES MOMENTS FOR THE MONITORS TO TURN ON AGAIN AND OTHER TIMES IT TAKES AROUND TEN MINS FOR THE MONITORS TO TURN BACK ON. ON (B)(6) 2007, THE SOFTWARE VERSION OF THE MONITORS WERE UPGRADED FROM VF6.2 TO VF6.4 AND THE MONITORS WERE KEPT UNDER OBSERVATION FOR ONE WEEK. THE PROBLEM WAS REPORTED AGAIN WITH THREE MONITORS. NO PT INJURY WAS REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KAPPA XLT | PATIENT MONITOR | MHX | DRAEGER MEDICAL SYSTEMS, INC. | MS14618 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |