MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2014-08-13 for GECKO NASAL PAD LGE - ROW manufactured by Resmed Ltd..
[17991764]
It was reported that a disoriented pt suffering from respiratory failure was connected to a philips respironics v60 respirator. A transparent silicone nasal pad was used with the mask. The nasal pad had slipped away from its position under the mask. It was in the pt's mouth, on top of the tongue. It could be seen between the lips and it was making breathing more difficult. The tidal volumes of the pt were decreased by 50%, breathing frequency increased further and saturation went down. The tidal volumes normalized as soon as the nasal pad was removed from the pt's mouth. Because of the pt's illness, intubation was necessary shortly after the incident.
Patient Sequence No: 1, Text Type: D, B5
[18230786]
There is no info to suggest a device malfunction. A clinical opinion was provided by resmed's vp of medical affairs; "the pt was in a monitored situation and, in respiratory failure. In such circumstances it would be reasonable to expect a high level of detection of this type of event. The pt was disoriented and so close monitoring would be expected. The device is large (in comparison to the airway) and malleable and these factors make it unlikely to cause permanent airway obstruction or choking. Gag and co2 reflexes will protect the airway in normal circumstances". The instructions for the gecko include visual cues on how to fit it correctly. The warnings are: do not clean with shampoo; do not place in microwave; do not place in dishwasher; keep product away from open flames; keep product away from direct sunlight; do not ingest or place in mouth. The gecko mask pad is a passive piece of equipment and resmed advises how to fit it correctly and to prevent ingestion or placing it in the mouth. It isn't clear how we could have reduced the risk to the pt by design and we don't have a clear understanding how the device got into the airway. In summary, there was no "fault" with the device as such, leading to pt risk. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004604967-2014-00019 |
| MDR Report Key | 4039873 |
| Report Source | 00,01 |
| Date Received | 2014-08-13 |
| Date Mfgr Received | 2014-07-14 |
| Date Added to Maude | 2014-08-28 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID DULEY, ENGINEER |
| Manufacturer Street | 9001 SPECTRUM CENTER BLVD. |
| Manufacturer City | SAN DIEGO CA 92123 |
| Manufacturer Country | US |
| Manufacturer Postal | 92123 |
| Manufacturer Phone | 8588365985 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GECKO NASAL PAD LGE - ROW |
| Product Code | FMP |
| Date Received | 2014-08-13 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED LTD. |
| Manufacturer Address | 1 ELIZABETH MACARTHUR DRIVE BELLA VISTA NEW SOUTH WALES NSW2153 AS NSW 2153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-13 |