MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO

Model Number	1020008
Medical Device Problem Codes	Crack (1135); Gas Output Problem (1266); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device was evaluated by a third-party service center.
Event or Problem Description
The manufacturer was contacted in reference to an everflo device with complaints of low o2 and the ac power cord cracked/loose.A everflo device was returned to a third-party service center for service.There was no report of patient harm or injury.There was no report of medical intervention.During the comprehensive inspection/evaluation the complaint was confirmed and the parts replaced.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
• Common Device Name: EVERFLO
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18560290
• Report Number: 2518422-2024-03652
• Device Sequence Number: 12465237
• Product Code: CAW
• UDI-Device Identifier: 00606959032576
• UDI-Public: 00606959032576
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 1020008
• Device Catalogue Number: 1020008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown