MAUDE Adverse Event Report: RESPIRONICS, INC. SIMPLYGO OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number 1069058

Device Problems Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 12/21/2015

Event Type  Death  

Event Description

The manufacturer received information that a patient expired while using a simplygo oxygen concentrator on an airplane.It was noticed the battery had depleted.It was reported, by the distributor, that when the patient ordered the device that it was only being used for nocturnal use and that one battery would be sufficient.The patient did not have back up oxygen.The simplygo device is not intended to be life-sustaining or life-supporting.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported a patient expired while using a simplygo oxygen concentrator on an airplane.It was observed that the battery had depleted.It was reported, by the distributor, that when the patient ordered the device that it was only being used for nocturnal use and that one battery would be sufficient.The patient did not have a backup supply of oxygen.The device is not returning to the manufacturer for evaluation.The manufacturer received information from the lawyers stating an expert in charge of a public prosecutor's office could not determine a defect on the device and the device was returned to (b)(6).It appears the device operated to design specifications.Loss of therapy for the patient population does not represent a significant risk to the intended user.The simplygo oxygen concentrator is not intended to be life sustaining or life-supporting.Product labeling states, "in an event of an equipment alarm or if you are experiencing any signs of discomfort consult your home care provider.Product labeling also states where the prescribing health care professional has determined that an interruption in the supply of oxygen, for any reason, may have serious consequences to the user, an alternate source of oxygen should be available for immediate use." the manufacturer concludes that based on the information received from the lawyers, the device operated properly.The device did not cause or contribute to the patient's death since the device is not a life sustaining or life support device.

• Brand Name: SIMPLYGO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• Manufacturer Contact: adam price ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 5366830
• MDR Text Key: 35960676
• Report Number: 1040777-2016-00002
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1069058
• Device Catalogue Number: 1069058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/05/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death