FDA Adverse Event
Death
Summary report: N
KING LARYNGEAL TUBE SIZE 5.0
MDR report key: 4627466
·
Received March 18, 2015
Report
- Report Number
- MW5041571
- Event Type
- Death
- Date Received
- March 18, 2015
- Date of Event
- March 1, 2015
- Report Date
- March 18, 2015
- Manufacturer
- KING SYSTEMS CORP
- Product Code
- CAE
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PT ARRESTED ON (B)(6) 2015. RESPONDERS INITIATED RESUSCITATIVE MEASURES, INCLUDING INSERTION OF A KING AIRWAY. RESUSCITATION ATTEMPT WAS UNSUCCESSFUL, PT WAS PRONOUNCED, AND TURNED OVER TO MEDICAL EXAMINER FOR POSTING. AUTOPSY RESULTS REVEALED AIRWAY "KINKED" OR BENT ON INSERTION. WAVEFORM AND DIGITAL CAPNOGRAPHY, AS WELL AS PHYSICAL EXAMINATION OF CHEST RISE AND BREATH SOUNDS INDICATED PT WAS BEING ADEQUATELY VENTILATED. THIS IS TO REPORT POTENTIAL DEFECT IN THE AIRWAY ITSELF. DIAGNOSIS OR REASON FOR USE: CARDIAC ARREST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184437 | KING LARYNGEAL TUBE SIZE 5.0 | KING LARYNGEAL AIRWAY | CAE | KING SYSTEMS CORP | SIZE 5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 01/27/1 | Death |