MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2009-08-05 for S/5 COMPACT AIRWAY MODULE manufactured by Ge Healthcare Finland Oy.
[19671240]
The model number for the pedi-lite spirometry sensor is 73393.
Patient Sequence No: 1, Text Type: N, H10
[19683146]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610105-2009-00031 |
| MDR Report Key | 1473684 |
| Report Source | 01,05,06 |
| Date Received | 2009-08-05 |
| Date of Report | 2009-08-05 |
| Date of Event | 2009-07-10 |
| Date Mfgr Received | 2009-07-07 |
| Date Added to Maude | 2010-09-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANN LEBAR |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD MAIL CODE - W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482757 |
| Manufacturer G1 | GE HEALTHCARE FINLAND OY |
| Manufacturer City | HELSINKI |
| Manufacturer Country | FI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S/5 COMPACT AIRWAY MODULE |
| Generic Name | CARBON DIOXIDE GAS ANALYZER |
| Product Code | CCL |
| Date Received | 2009-08-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE FINLAND OY |
| Manufacturer Address | HELSINKI FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-05 |