MAUDE Adverse Event Report: RESPIRONICS, INC. CYLINDER,ULTRAFILL,MB08,3000 PSI; GENERATOR, OXYGEN, PORTABLE

Model Number	1065715
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an oxygen cylinder became disconnected from the ultrafill device.There was no report of patient harm or injury.The investigation is still ongoing.A follow up report will be filed when the manufacturer has completed the investigation.
Additional Manufacturer Narrative
The manufacturer previously reported an oxygen cylinder allegedly became disconnected from the ultrafill device.There was no report of patient harm or injury.The device was returned to the manufacturer for evaluation.The customer's complaint was not duplicated.

• Brand Name: CYLINDER,ULTRAFILL,MB08,3000 PSI
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• MDR Report Key: 7270684
• Report Number: 1040777-2018-00004
• Device Sequence Number: 13706786
• Product Code: CAW
• UDI-Device Identifier: 00606959032477
• UDI-Public: 00606959032477
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 01/24/2018

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: 1065715
• Device Catalogue Number: 1065715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/14/2018
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ULTRAFILL DEVICE, SERIAL NUMBER (B)(4)