N
Patient 1
THE MODEL NUMBER FOR THE PEDI-LITE SPIROMETRY SENSOR IS 73393.
MAUDE MDR 1473684
- MDR report key
- 1473684
- Report number
- 9610105-2009-00031
- Event key
- 0
- Event type
- 3
- Date of event
- 2009-07-10
- Date received
- 2009-08-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- ANN LEBAR
- Address
- 3000 N. GRANDVIEW BLVD MAIL CODE - W450 WAUKESHA WI 53188 US
- Phone
- 262-262-2625
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | S/5 COMPACT AIRWAY MODULE | CARBON DIOXIDE GAS ANALYZER | GE HEALTHCARE FINLAND OY | CCL | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-08-05 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT A PT WAS UNABLE TO BE VENTILATED DUE TO A PROBLEM WITH THE BREATHING CIRCUIT THAT WAS ATTACHED TO A PEDI-LITE SPIROMETRY SENSOR. THE PT WAS REPORTED TO BE SPONTANEOUSLY VENTILATING ON LARYNGEAL MASK. AN OPIATE WAS GIVEN AND THE RESPIRATORY RATE AND DEPTH REDUCED. POSITIVE PRESSURE VENTILATION WAS ATTEMPTED BUT WAS IMPOSSIBLE. PT RECEIVED TREATMENT FOR VARIOUS CAUSES OF DIFFICULTY VENTILATING UNDER ANESTHESIA. ALL PARTS OF THE ANESTHETIC CIRCUIT WERE REPORTEDLY CHANGED EXCEPT THE SPIROMETRY TUBING ATTACHED TO THE ANESTHETIC MACHINE. THIS IS MADE OF CLEAR YELLOW PLASTIC, AND THERE WAS NO OBSTRUCTION UPON VISUAL INSPECTION. PT WAS DISCONNECTED FROM THE ANESTHETIC CIRCUIT JUST PRIOR TO BRONCHOSCOPY AND WAS CONNECTED TO AMBUBAG - NORMAL CHEST EXCURSION. A SMALL PIECE OF PLASTIC PACKAGING WAS THEN SEEN TO POP OUT OF THE SPIROMETRY TUBING. IT APPEARED TO LOOK LIKE A CLEAR PLASTIC FILM AND IS THOUGHT TO HAVE COME FROM THE PEDI-LITE PACKAGING. IT IS BELIEVED THAT THIS FILM WAS ACTING AS A FLAP VALVE WITHIN THE CIRCUIT ALLOWING NORMAL SPONTANEOUS VENTILATION PUT PREVENTING POSITIVE PRESSURE VENTILATION. THE PT REPORTEDLY WORK UP NORMALLY FROM THE INCIDENT WITH NO RESIDUAL EFFECTS. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.