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

Model Number 61913

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 06/10/2014

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.

• Brand Name: GECKO NASAL PAD LGE - ROW
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur dr.; bella vista NSW 2153; AS NSW 2153
• Manufacturer (Section G): RESMED CORP; 9001 spectrum center boulevard; --; san diego CA 92123 000
• Manufacturer Contact: 9001 spectrum center boulevard; --; san diego, CA 92123-0000
• MDR Report Key: 4039912
• MDR Text Key: 4902671
• Report Number: 3007573469-2014-00008
• Device Sequence Number: 1
• Product Code: FMP
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 61913
• Device Catalogue Number: 61913
• Device Lot Number: E10L09201382
• Other Device ID Number: PR764613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/14/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention