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

Model Number 1020000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/25/2019

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient had an allergic reaction when an oxygen concentrator was unpackaged at their home by the durable medical equipment supplier (dme).The patient alleges she had to use her epi-pen, but did not seek medical attention.The device was not in patient use.The device was removed from the patient's home immediately.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• 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: 9452246
• MDR Text Key: 176269840
• Report Number: 1040777-2019-00049
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1020000
• Device Catalogue Number: 1020000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 29 YR