MAUDE Adverse Event Report: RESMED LTD S9 AUTOSET - ANZ; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 36305

Device Problem Device Stops Intermittently (1599)

Patient Problem Atrial Fibrillation (1729)

Event Date 02/11/2016

Event Type  Injury  

Manufacturer Narrative

The device was returned to the resmed design house located in (b)(6) for an extensive engineering investigation.A preliminary evaluation of the device data was performed and determined that there was no indication of an error leading to the device stopping therapy.Based on available evidence at this time, there is no indication that a device malfunction contributed to the reported event.The investigation methods, results, and conclusion are not finalized at this stage.The risk has been reviewed and deemed to be acceptable in the risk analysis document.Resmed reference #: (b)(4).

Event Description

It was reported to resmed (b)(4) that a patient using an s9 autoset developed atrial fibrillation resulting in hospitalization and cardioversion.It was alleged that the device was not working at the time the patient developed these medical conditions.

Manufacturer Narrative

An extensive engineering investigation was performed on the returned unit.The device powered on and operated normally upon receipt at resmed.Performance testing could not confirm the reported complaint that the device was not working.A visual inspection of the device found water contamination of the main pcb.The investigation determined that there was no evidence to support an error occured leading to the device stopping therapy at the time of the event.There is no indication that a device malfunction contributed to the reported event.(b)(4).

• Brand Name: S9 AUTOSET - ANZ
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista, nsw 2153 ; AS 2153
• Manufacturer Contact: david duley ; 9001 spectrum center blvd; san diego, CA 92123 ; 8588365985
• MDR Report Key: 5495730
• MDR Text Key: 40178029
• Report Number: 3004604967-2016-00260
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K091947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 36305
• Device Catalogue Number: 36305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/08/2017
• Device Age: 4 YR
• Date Manufacturer Received: 01/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other