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

Model Number 1113605

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 03/29/2020

Event Type  Death  

Event Description

The manufacturer received information alleging an oxygen concentrator was not functioning properly.The patient's blood oxygen level was low.The patient expired at a later date.It is unknown if the patient was using the device at the time of death.The investigation is still ongoing for this issue.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported an oxygen concentrator allegedly was not functioning properly.The patients blood oxygen level was low.The patient expired at a later date, date unknown.It is unknown if the patient was using the device at the time of death.The device was returned to the manufacturer's quality product investigation laboratory for further investigation.The customer's complaint of the oxygen concentrator not working properly was not confirmed.The manufacturer tested the device and found the device to operate and alarm to design specifications.The manufacturer attempted to gather further information about the event but the family stated no additional information will be provided.The manufacturer concludes the device did not cause or contribute to the patient's death.

• Brand Name: SIMPLYGO MINI OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): PHILIPS RESPIRONICS INC.; 1001 murry ridge lane; murrysville, pa
• MDR Report Key: 9920587
• MDR Text Key: 186289658
• Report Number: 2518422-2020-00825
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K111885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

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
• Device Operator: Health Professional
• Device Model Number: 1113605
• Device Catalogue Number: 1113605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Initial Date Manufacturer Received: 03/29/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 04/15/2020
• Supplement Dates FDA Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death