MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-08-13 for GECKO NASAL PAD LGE - ROW 61913 manufactured by Resmed Ltd.
[4902671]
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
| Report Number | 3007573469-2014-00008 |
| MDR Report Key | 4039912 |
| Report Source | 99 |
| Date Received | 2014-08-13 |
| Date of Report | 2014-08-13 |
| Date of Event | 2014-06-10 |
| Date Facility Aware | 2014-07-14 |
| Date Added to Maude | 2014-08-28 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 Street | 9001 SPECTRUM CENTER BOULEVARD -- |
| Manufacturer City | SAN DIEGO CA 921230000 |
| Manufacturer Country | US |
| Manufacturer Postal | 921230000 |
| Manufacturer G1 | RESMED CORP |
| Manufacturer Street | 9001 SPECTRUM CENTER BOULEVARD -- |
| Manufacturer City | SAN DIEGO CA 92123000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92123 0000 |
| Single Use | 0 |
| 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 |
| Model Number | 61913 |
| Catalog Number | 61913 |
| Lot Number | E10L09201382 |
| ID Number | PR764613 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED LTD |
| Manufacturer Address | 1 ELIZABETH MACARTHUR DR. BELLA VISTA NSW2153 AS NSW 2153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-13 |