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

Model Number 1065715

Device Problems Disconnection (1171); Connection Problem (2900)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2015

Event Type  malfunction  

Event 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 device has yet to be evaluated by the manufacturer.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer has completed the investigation of an oxygen cylinder that allegedly became disconnected from an ultrafill device.There was no report of patient harm or injury.The device was returned to the manufacturer for evaluation.The ultrafill device was tested and found to operate to design specifications.The manufacturer determined that the cause of the oxygen cylinder separation from the ultrafill device was due to a damaged post valve thread to the inlet fill fitting of the cylinder.

• Brand Name: ULTRAFILL MB08 CYLINDER
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS INC.; 175 chastain meadows court; kennesaw GA 30144
• Manufacturer (Section G): RESPIRONICS INC; 175 chastain meadows court; kennesaw GA 30144
• Manufacturer Contact: wilfredo alvarez ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 4532164
• MDR Text Key: 15105560
• Report Number: 1040777-2015-00009
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2015

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
• Device Operator: Lay User/Patient
• Device Model Number: 1065715
• Device Catalogue Number: 1065715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 02/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1