FDA Adverse Event
Malfunction
Summary report: N
SPACELABS ARKON ANESTHESIA WORKSTATION
MDR report key: 5091154
·
Received September 21, 2015
Report
- Report Number
- 9611295-2015-00023
- Event Type
- Malfunction
- Date Received
- September 21, 2015
- Date of Event
- May 22, 2015
- Report Date
- June 2, 2020
- Manufacturer
- SPACELABS HEALTHCARE LTD.
- Product Code
- CBK
- PMA / PMN Number
- K113051
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
10-JUN-2016: MFR REPORT (B)(4) WAS DISCOVERED TO BE A DUPLICATE OF MFR REPORT #9611295-2015-00021, (B)(4) (FILED ON SEPTEMBER 18, 2015), AND HENCE FILED IN ERROR. MFR REPORT IS CONSIDERED CLOSED.
Description of Event or Problem · 1
SPACELABS RECEIVED A REPORT THAT ON (B)(6) 2015, AN ARKON ANESTHESIA MACHINE FAILED TO VENTILATE WHEN THE BAG / VENT SWITCH WAS ENGAGED AT THE START OF A CASE. NO ONE WAS INJURED AS THE RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 624126 | SPACELABS ARKON ANESTHESIA WORKSTATION | ANESTHESIA WORKSTATION WITH CONTINUOUS VENTILATOR | CBK | SPACELABS HEALTHCARE LTD. | 99999 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |