FDA Adverse Event
Malfunction
Summary report: N
KION
MDR report key: 3832521
·
Received March 17, 2014
Report
- Report Number
- 8010042-2014-00093
- Event Type
- Malfunction
- Date Received
- March 17, 2014
- Date of Event
- February 28, 2014
- Report Date
- February 28, 2014
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- BSZ
- PMA / PMN Number
- K024213
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A COMPANY FIELD SERVICE ENGINEER HAS BEEN ON SITE AND HAS STARTED THE INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN THE INVESTIGATION HAS BEEN FINALIZED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE ON A PATIENT, THE ANESTHESIA WORKSTATION FAILED TO DELIVER GAS TO THE PATIENT. THE PATIENT SATURATION LEVEL (SP02) DECREASED TO APPROXIMATELY 80 BUT NO HARM TO THE PATIENT WAS REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157196 | KION | BSZ | MAQUET CRITICAL CARE AB | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |