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

Model Number IRC5PO2V

Device Problems Device Alarm System (1012); Gas Output Problem (1266); Out-Of-Box Failure (2311)

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

Event Type  malfunction  

Manufacturer Narrative

No end user information provided.An rma has been issued but product not returned at the time of this investigation/filing.A follow up will be sent if additional information is received.

Event Description

Dealer advised low o2 at 82 percent with no alarm out of the box from order (b)(4) with four hours.Dealer does not indicate whether lack of visual or audible alarm.

Manufacturer Narrative

The result of the evaluation was that the o2 levels were within specification and no problem was found, which does not confirm the original complaint issue.

Event Description

Dealer advised low o2 at 82 percent with no alarm out of the box from order (b)(4) with four hours.Dealer does not indicate whether lack of visual or audible 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: 5108232
• MDR Text Key: 27001772
• Report Number: 1031452-2015-16098
• 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
• Report Date: 09/29/2015

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: IRC5PO2V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• 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