MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL); 868.5440

Model Number IRC5PO2V

Device Problem No Display/Image (1183)

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

Event Type  malfunction  

Event Description

Dealer states unit alarms after a few minutes of running.Rental unit, no patient id.

• Brand Name: PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
• Type of Device: 868.5440
• Manufacturer (Section D): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE REHABILITATION EQUIP; no.435 xieyu street; suzhou industrial park; jiangsu, p.rc. 2150 26; CH 215026
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4239362
• MDR Text Key: 4990530
• Report Number: 3008262382-2014-01911
• 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
• Type of Report: Initial
• Report Date: 10/21/2014

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2014
• Initial Date FDA Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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