MAUDE Adverse Event Report: RESMED LTD. GECKO NASAL PAD LGE - ROW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.".

• Brand Name: GECKO NASAL PAD LGE - ROW
• Manufacturer (Section D): RESMED LTD.; 1 elizabeth macarthur drive; bella vista new south wales NSW 2153; AS NSW 2153
• Manufacturer Contact: david duley, engineer ; 9001 spectrum center blvd.; san diego, CA 92123 ; 8588365985
• MDR Report Key: 4039873
• MDR Text Key: 17991764
• Report Number: 3004604967-2014-00019
• Device Sequence Number: 1
• Product Code: FMP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 07/14/2014
• Initial Date FDA Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1