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

Model Number	1020010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	05/08/2023
Type of Reportable Event	Death
Event or Problem Description
The manufacturer became aware of an allegation that a user of an everflo intl.Opi concentrator lost power due to local power blackout outage.The user was found on the floor next to her bedside tables deceased.The son stated that he thought his mum was trying to get the oxygen bottles and fell.The user was registered as a life-support patient with the electric company, which during scheduled maintenance outages family members are notified but not in the case during an unplanned blackout.Allegation as described in the newspaper article was not due to device malfunction however the concern that the power outage shut off the concentrator and therefore oxygen supply to the patient ceased.The user needed the oxygen for her emphysema.The family has not returned calls requesting the device be returned.No product returning.If further information becomes available regarding this complaint, a follow up report will be submitted.
Additional Manufacturer Narrative
H3 other text : family not responding to return the device.
Additional Manufacturer Narrative
Based on information provided and available, this event is assessed as an unintentional, use error ¿ failure to use a backup oxygen supply amidst a power outage as per stated in the ifu.While the patient did have backup oxygen bottles, she unfortunately was unable to get to them in time.This device is not indicated for life sustaining/supporting purposes.Thus, if the patient passed from loss of low flow o2, it is more likely the patient should have been on a different device that would have provided more adequate therapy.No further action is required.

• Brand Name: EVERFLO INTL OPI CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17000133
• Report Number: 2518422-2023-12111
• Device Sequence Number: 6724061
• Product Code: CAW
• UDI-Device Identifier: 00606959001077
• UDI-Public: 00606959001077
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1020010
• Device Catalogue Number: 1020010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 80 YR
• Patient Sex: Female