MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO DOM NON- OPI 120V US/CAN; GENERATOR, OXYGEN, PORTABLE

Model Number 1020000

Device Problems Device Alarm System (1012); Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : the device was evaluated by a fasc.

Event Description

The manufacturer received information related to an everflo oxygen concentration.Per the work order received, the customer's complaint was confirmed - continuous alarms, sieve beds blown, solenoid intermittent, regulator damaged, and the power cord chewed up.During the evaluation from the fasc, the following were replaced: 1038825, 1114952, 1038824, 1129417, 1038842, 1038831, and 1039642.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.

• Brand Name: EVERFLO DOM NON- OPI 120V US/CAN
• Type of Device: 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: 18207997
• MDR Text Key: 328962704
• Report Number: 2518422-2023-31582
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959014954
• UDI-Public: 00606959014954
• 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: Other,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1020000
• Device Catalogue Number: 1020000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1