MAUDE Adverse Event Report: RESPIRONICS, INC. CYLINDER,ULTRAFILL,ME36,3000 PSI; GENERATOR, OXYGEN, PORTABLE

Model Number 1065722

Device Problems Disconnection (1171); Material Rupture (1546); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2019

Event Type  malfunction  

Event Description

The manufacturer received information alleging a cylinder became disconnected from an ultrafill device.There was no report of patient harm or injury.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be filed when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported a cylinder allegedly became disconnected from the device.There was no report of patient harm or injury.The cylinder was returned to the manufacturer's service center.The manufacturer confirmed the burst disk ruptured in the cylinder causing the cylinder to release pressure.The manufacturer also found the knob to be bent and damage to the fill fitting.

Manufacturer Narrative

The manufacturer previously reported an incorrect device problem code, 3189-no apparent adverse event, on the previously submitted report.The device problem code is corrected on this report.  .

• Brand Name: CYLINDER,ULTRAFILL,ME36,3000 PSI
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668 3724
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 8712763
• MDR Text Key: 148440159
• Report Number: 1040777-2019-00031
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K091191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2023

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: 1065722
• Device Catalogue Number: 1065722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 08/20/2019; 04/13/2023
• Supplement Dates FDA Received: 08/28/2019; 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: ULTRAFILL DEVICE SN (B)(4); ULTRAFILL DEVICE SN (B)(4)