MAUDE Adverse Event Report: RESMED LTD AUTOSET CS-A - TEIJIN

Model Number 36351

Device Problem Unexpected Shutdown (4019)

Patient Problems Death (1802); Low Oxygen Saturation (2477)

Event Type  Death  

Manufacturer Narrative

The device was returned to the distributor and passed performance testing.Device data logs were provided to resmed for an evaluation.Based on both evaluations, the device was confirmed to have been performing to specification.The autoset cs-a user guide provides the following contraindication: ¿asv therapy is contraindicated in patients with chronic, symptomatic heart failure (nyha 2-4) with reduced left ventricular ejection fraction (lvef <45%) and moderate to severe predominant central sleep apnoea.¿ the user guide also warns that: - ¿patients should report unusual chest pain, severe headache, or increased breathlessness to their prescribing physician.¿ note: further information regarding the trial and remedial action can be found in medwatch 3004604967-2015-00176.In this case, resmed was unable to determine if the desaturation was directly caused by the brief stop in therapy, due to limited information about the patient¿s condition.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that a patient on an s9 autoset cs device experienced desaturation.The device was found to have stopped but was restarted and operated without any issues.The patient was placed on a replacement device on the same night.It was reported that the patient had subsequently expired the next night.

• Brand Name: AUTOSET CS-A - TEIJIN
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer (Section G): RESMED CORP; 9001 spectrum center blvd; san diego CA 92123
• Manufacturer Contact: ariana beck ; 9001 spectrum center blvd; san diego, CA 92123
• MDR Report Key: 8110651
• MDR Text Key: 128597732
• Report Number: 3004604967-2018-01702
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K113801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 11/28/2018

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: 36351
• Device Catalogue Number: 36351
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/23/2018
• Device Age: 51 MO
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death