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

Model Number IRC10LXO2

Device Problems No Audible Alarm (1019); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Product has not been returned for evaluation as of the date of this investigation.Rma was issued.If new information becomes available at a later date this complaint will be updated and/or a follow up be sent.

Event Description

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

Manufacturer Narrative

Product has been returned and evaluated.The underlying cause documented on the return fields (tw) in oracle is identified as: assembly/component issue: controls, switch /button broken.

Event Description

Dealer states, the alarm is not sounding and its' 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: 5052727
• MDR Text Key: 25628657
• Report Number: 1031452-2015-15818
• 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
• Type of Report: Initial
• 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?: Yes
• 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: 08/07/2015
• 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