MAUDE Adverse Event Report: RESPIRONICS, INC. ULTRAFILL OXYGEN DEVICE; GENERATOR, OXYGEN, PORTABLE

Model Number	1057100
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a cylinder separated from the ultrafill device.There was no report of patient harm or injury.The utlrafill device and cylinder were returned to the manufacturer for evaluation.The ultrafill device was tested and was found to operate to design specifications.The cylinder was tested and the fill fitting has separated from the post valve.This occurs when excessive force has been applied to tighten the fitting to the point the brass has fractured but not fully separated from the post valve.Visual inspection of the cylinder was completed by the manufacturer.The manufacturer found evidence of markings caused by a tool used for overtightening of the fitting.This occurred in the field, not during manufacturing.

• Brand Name: ULTRAFILL OXYGEN DEVICE
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• MDR Report Key: 6898008
• Report Number: 1040777-2017-00031
• Device Sequence Number: 705528
• Product Code: CAW
• UDI-Device Identifier: 00606959032477
• UDI-Public: 00606959032477
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 09/06/2017

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: Lay User/Patient
• Device Model Number: 1057100
• Device Catalogue Number: 1057100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1