MAUDE Adverse Event Report: PHILIPS RESPIRONICS INC. HEALTHDYNE ALLIANCE OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Device Problem Use of Device Problem (1670)

Patient Problem Death (1802)

Event Date 10/27/2014

Event Type  Death  

Event Description

The manufacturer received information alleging a healthdyne alliance oxygen concentrator did not provide oxygen to the patient.It was reported that the humidifier bottle was not connected correctly.The patient expired.The investigation is still ongoing.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported a healthdyne alliance oxygen concentrator allegedly did not provide oxygen to the patient.It was reported that the humidifier bottle was not connected correctly.The patient expired.It was reported that the death certificate states the patient died of a sudden cardiac death.Repeated attempts to have the device returned for evaluation and investigation were unsuccessful.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: HEALTHDYNE ALLIANCE OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): PHILIPS RESPIRONICS INC.; 312 alvin drive; new kensington PA 15068 3724
• MDR Report Key: 8837277
• MDR Text Key: 152521998
• Report Number: 1040777-2019-00037
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K942357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death