MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS PLATINUM 10 CONCEN W/SENS O2 9153642105; GENERATOR, OXYGEN, PORTABLE

Model Number IRC10LXO2

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available for the patient, a supplemental record will be filed.

Event Description

Dealer states the alarm is not sounding and its' due to a failure of the pc board.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.The result of the evaluation was that the power switch/button was broken causing the alarm not to function, which confirmed the original complaint issue.

Event Description

Dealer states the alarm is not sounding and it's due to a failure of the pc board.

• Brand Name: PLATINUM 10 CONCEN W/SENS O2 9153642105
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5052697
• MDR Text Key: 25580568
• Report Number: 1031452-2015-15813
• 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: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Repair
• Report Date: 09/10/2015

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: IRC10LXO2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other