MAUDE Adverse Event Report: RESMED LTD OBSOLETE S9 VPAP ST - AMERICAS

Model Number 36008

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

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Resmed has requested for the device to be returned for an engineering investigation and requested additional information surrounding the nature of the event.At this time there is no information that suggests the device contributed to the death.If additional information is made available or the device is returned for an investigation then resmed will submit a follow-up report with the appropriate narrative.(b)(4).

Event Description

It was reported to resmed that a patient on an s9 vpap st device expired.The patient was reported to have stopped breathing while on bi-pap therapy.There was no allegation of a device malfunction or that the device contributed to the patient death.

• Brand Name: OBSOLETE S9 VPAP ST - AMERICAS
• 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: david duley ; 9001 spectrum center blvd; san diego, CA 92123
• MDR Report Key: 7068891
• MDR Text Key: 93281816
• Report Number: 3004604967-2017-01695
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/29/2017

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: 36008
• Device Catalogue Number: 36008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/30/2017
• Device Age: 45 MO
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/29/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death