MAUDE Adverse Event Report: RESMED LTD. VPAP AUTO 25 AMERICAS; VENTILATOR, NON-CONTINUOUS, RESPIRATOR

Device Problem Device Inoperable (1663)

Patient Problem Respiratory Distress (2045)

Event Type  malfunction  

Event Description

Please refer importer report #: 3007573469-2015-00018.

Manufacturer Narrative

It was reported to resmed that at the time of the event the device was found turned-off.A preliminary eval was performed in (b)(4).The results of the eval were unable to find a fault with the device.The device is currently being returned to the mfg facility located in (b)(4) for an engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.Resmed ref.#:(b)(4).

• Brand Name: VPAP AUTO 25 AMERICAS
• Type of Device: VENTILATOR, NON-CONTINUOUS, RESPIRATOR
• Manufacturer (Section D): RESMED LTD.; 1 elizabeth macarthur drive; bella vista new south wales 2153 ; AS 2153
• Manufacturer Contact: david duley, qlty engr ; 9001 spectrum center blvd.; san diego, CA 92123 ; 8588365985
• MDR Report Key: 4489988
• MDR Text Key: 5564937
• Report Number: 3004604967-2015-00018
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K080131
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2010
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1