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

Model Number 36351

Device Problems Display or Visual Feedback Problem (1184); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed for an engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.When more information is available a supplemental report will be submitted.(b)(4).

Event Description

It was reported to resmed that a patient had an oxygen desaturation and the s9 autoset cs-a device was found by the nurse to be stopped while in use on the patient and inoperable.It was reported that the patient was placed on a different device and oxygen saturation recovered.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

The s9 autoset cs-a device was returned to resmed for an investigation.Performance testing confirmed the reported complaint.Disassembly and visual inspection of the device revealed evidence of water ingress.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to water ingress of the device main pcba.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 that a patient had an oxygen desaturation and the s9 autoset cs-a device was found by the nurse to be stopped while in use on the patient and inoperable.It was reported that the patient was placed on a different device and oxygen saturation recovered.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: AUTOSET CS-A - TEIJIN
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 8587063
• MDR Text Key: 144409524
• Report Number: 3004604967-2019-00158
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K160822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 36351
• Device Catalogue Number: 36351
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2019
• Distributor Facility Aware Date: 07/15/2019
• Device Age: 59 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2019
• Date Manufacturer Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1