FDA Adverse Event
Malfunction
Summary report: N
SPACELABS MULTIGAS MODULE
MDR report key: 3211572
·
Received July 8, 2013
Report
- Report Number
- 3023361-2013-00029
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 3, 2013
- Report Date
- April 24, 2013
- Manufacturer
- SPACELABS MEDICAL INC.
- Product Code
- CBR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
NO ONE WAS INJURED AS A RESULT OF THIS EVENT. SPACELABS IS EVALUATING THIS EVENT AND WILL FILE A F/U REPORT WHEN OUR EVAL IS CONCLUDED.
Description of Event or Problem · 1
THE CUSTOMER HAS A 92518 GAS MODULE CONNECTED TO XPREZZON MONITOR. THE CUSTOMER REPORTED, "THE GAS PARAMETER BEGAN TO FLICKER AND BLINK, THEN FINALLY LOST COMMUNICATION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312128 | SPACELABS MULTIGAS MODULE | CBR: MULTIGAS ANALYZER | CBR | SPACELABS MEDICAL INC. | 92518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | (B)(4) |