MAUDE Adverse Event Report: PHILIPS RESPIRONICS INC. EVERFLO OXYGEN CONCENTRATOR OPI; GENERATOR, OXYGEN, PORTABLE

Model Number 1020007

Device Problem Human-Device Interface Problem (2949)

Patient Problem Death (1802)

Event Date 03/28/2019

Event Type  Death  

Event Description

The manufacturer received information alleging the patient mistakenly used the humidifier tubing instead of the oxygen tubing.It was reported that the patient had a tracheostomy.The patient expired.There was no allegation of device malfunction that occurred.The device is currently in the possession of the police and is not being returned to the manufacturer for evaluation at this time.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer received information alleging the patient mistakenly used the humidifier tubing instead of the oxygen tubing.It was reported that the patient had a tracheostomy.The patient expired.There was no allegation of device malfunction that occurred.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: EVERFLO OXYGEN CONCENTRATOR OPI
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): PHILIPS RESPIRONICS INC.; 312 alvin drive; new kensington PA 15068 3724
• MDR Report Key: 8470573
• MDR Text Key: 140519126
• Report Number: 1040777-2019-00018
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959032569
• UDI-Public: 00606959032569
• Combination Product (y/n): N
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1020007
• Device Catalogue Number: 1020007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: 10/31/2019
• Supplement Dates FDA Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death