FDA Adverse Event
Malfunction
Summary report: N
AISYS
MDR report key: 5369491
·
Received January 15, 2016
Report
- Report Number
- 2112667-2016-00072
- Event Type
- Malfunction
- Date Received
- January 15, 2016
- Date of Event
- December 17, 2015
- Report Date
- March 28, 2016
- Manufacturer
- DATEX-OHMEDA, INC.
- Product Code
- BSZ
- PMA / PMN Number
- K042154
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. INITIAL REPORTER: THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. THE HOSPITAL REPORTED THEY REBOOTED THE UNIT AND RESOLVED THE REPORTED COMPLAINT. THE UNIT WAS RETURNED TO SERVICE.
Additional Manufacturer Narrative · 1
UPDATED FROM "AESTIVA 7100" TO "AISYS". THE COMMON DEVICE NAME AND PROCODE REMAINED THE SAME "ANESTHESIA GAS MACHINE" AND "BSZ" RESPECTIVELY. THE PMA/510(K) # WAS UPDATED FROM "K000706" TO "K042154". THE DATE OF DEVICE MANUFACTURE WAS CHANGED FROM "08/2009" TO "08/2014".
Description of Event or Problem · 1
THE HOSPITAL REPORTED THE UNIT HAD A BLANK SCREEN AND MECHANICAL VENTILATION WAS NOT FUNCTIONAL. THERE WAS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29136 | AISYS | ANESTHESIA GAS MACHINE | BSZ | DATEX-OHMEDA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |