MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV MILLENNIUM M10; GENERATOR, OXYGEN, PORTABLE

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 04/10/2018

Event Type  Injury  

Event Description

Oxygen concentrator failure.The unit failed from a loose water bottle and my wife went to the er and spent two days in the hospital.So far i have found three problems with these units: they may not detect commercial power failure; they may not detect a loose water bottle; they do not detect a lack of air to the pt.So far i have contacted three mrs and only one covers two (1 and 2) of these problems.A rehab facility uses this device.

• Brand Name: MILLENNIUM M10
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
• MDR Report Key: 7446358
• MDR Text Key: 106215889
• Report Number: MW5076572
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR