MAUDE Adverse Event Report: RESMED LTD AUTOSET CS-A - TEIJIN; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 36351

Device Problem Device Stops Intermittently (1599)

Patient Problem Respiratory Acidosis (2482)

Event Date 01/28/2016

Event Type  Injury  

Manufacturer Narrative

An investigation carried out by the (b)(6) hospital determined that there was no device malfunction and confirmed that the device works as per specification.The device was not returned to resmed for investigation.Resmed's risk analysis for this adverse event concludes that the risk is acceptable.Resmed reference #: (b)(4).

Event Description

It was reported to resmed (b)(4) that a hospital patient's co2 narcosis condition worsened after an s9 autoset allegedly stopped delivering therapy.

• Brand Name: AUTOSET CS-A - TEIJIN
• 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: 5461813
• MDR Text Key: 39077570
• Report Number: 3004604967-2016-00171
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051364
• 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
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• 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
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/29/2016
• Device Age: 22 MO
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2014
• 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