MAUDE Adverse Event Report: RESMED LTD S9 VPAP ST - EUR2; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 36228

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

Patient Problem Death (1802)

Event Date 10/28/2015

Event Type  Death  

Manufacturer Narrative

The device was returned to the resmed design house located in (b)(4) for an extensive engineering investigation.The methods, results, and conclusion are not finalized at this stage.A preliminary inspection carried out by the hospital and initial review of the data recorded in device memory does not show any evidence of device malfunction.External and internal visual inspection didn't find any anomaly.The device is able to power up normally and deliver therapy.Further investigation of the device in progress.Once the investigation is complete a follow-up report will be submitted.Resmed's risk analysis for this failure modes concludes that the risk is acceptable.(b)(4).

Event Description

It was reported to resmed (b)(4) that a patient with severe underlying medical conditions passed away while using an s9 vpap st.

Manufacturer Narrative

An extensive engineering investigation was performed on the returned s9 vpap st at the resmed design house located in (b)(4).The investigation determined that the device passed all performance testing and worked according to specification.No faults that could contribute to the patient's death were found.Resmed's risk analysis for this reported event concludes that the risk is acceptable.(b)(4).

• Brand Name: S9 VPAP ST - EUR2
• 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: 5283295
• MDR Text Key: 33097185
• Report Number: 3004604967-2015-00690
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K091947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2016

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: 36228
• Device Catalogue Number: 36228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/26/2016
• Device Age: 13 MO
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2014
• 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): Death