MAUDE Adverse Event Report: RESMED LTD OBSOLETE S9 ESCAPE - AMERICAS

Model Number 36001

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

Patient Problem Seizures (2063)

Event Type  Injury  

Manufacturer Narrative

The device was received by resmed and an engineering evaluation was performed.Performance testing of the device determined that the device met specification.No fault was found with the device that lead to the adverse event.Resmed clinical staff reviewed the event as well as current literature.Per their review there is no information linking cpap therapy to seizures.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

Event Description

It was reported to resmed a patient using a s9 escape device had a seizure and was taken to the emergency room.

• Brand Name: OBSOLETE S9 ESCAPE - AMERICAS
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney 2153 ; AU 2153
• Manufacturer (Section G): RESMED CORP; 9001 spectrum center blvd; san diego CA 92123
• Manufacturer Contact: david duley ; 9001 spectrum center blvd; san diego, CA 92123
• MDR Report Key: 6201390
• MDR Text Key: 63185667
• Report Number: 3004604967-2016-01416
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/22/2016

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: 36001
• Device Catalogue Number: 36001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/29/2016
• Device Age: 6 YR
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1