MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS PERFECTO2 V WITH SENSOR 9153650799; GENERATOR, OXYGEN, PORTABLE

Model Number IRC5PO2V

Device Problems Loss of Power (1475); 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

Provider states the unit has an error code of 1 red 3 green, shutting off after a few minutes.Provider states upon start up the unit does not alarm.

Manufacturer Narrative

Additional/updated information was added to reflect the compressor being returned to the manufacturer for evaluation.The result of the evaluation was that the compressor was noisy.However, that is not enough information to confirm the reported problem of the unit having a 1 red, 3 green error code.The power switch will not be returned for evaluation, so the reported problem of the unit not alarming upon startup will not be confirmed.

Event Description

Provider states the unit has an error code of 1 red 3 green, shutting off after a few minutes.Provider states upon start up the unit does not alarm.

• Brand Name: PERFECTO2 V WITH SENSOR 9153650799
• 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: 5390182
• MDR Text Key: 37012226
• Report Number: 1031452-2016-00303
• 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: Replace
• Type of Report: Initial,Followup
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC5PO2V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2016
• 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