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

Model Number	1068987
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a simplygo oxygen concentrator shut off during patient use.The patient became cyanotic and was transported to the hospital.The patient has not yet been released from the hospital.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.
Additional Manufacturer Narrative
The manufacturer previously reported a simplygo oxygen concentrator that allegedly shut off during patient use.The patient became cyanotic and was transported to the hospital.The manufacturer received information from the reporting facility stating the device is not returning for evaluation.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: SIMPLYGO OXYGEN CONCENTRATION
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): PHILIPS RESPIRONICS INC.; 312 alvin drive; new kensington PA 15068
• MDR Report Key: 8449109
• Report Number: 1040777-2019-00015
• Device Sequence Number: 11516562
• Product Code: CAW
• UDI-Device Identifier: 00606959005723
• UDI-Public: 00606959005723
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1068987
• Device Catalogue Number: 1068987
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 22 YR