MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS INVACARE HOMEFILL II OXYGEN COMPRESSOR 9153635497; GENERATOR, OXYGEN, PORTABLE

Model Number IOH200

Device Problems Filling Problem (1233); Device Stops Intermittently (1599)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

Multiple attempts have been made for additional information.If additional information should become available, this record will be updated accordingly.The end user's prescribed flow rate is unknown.User¿s manual review- (1100873 rev.K, page 12) the maximum patient flow while filling a cylinder with the ioh200 is 3 l/min for platinum 5, xl and perfecto2 concentrators and 5 l/min for platinum 10 concentrators.Patients with a higher prescribed flow should not fill a cylinder while receiving supplemental oxygen treatment from the platinum concentrator.

Event Description

The end user is alleging that the homefill unit is not working.The end user is advising that the tank will not fill.The end user is alleging that the unit has been working off and on for the past few weeks.The end user is alleging that since the homefill has not been working properly it has caused the end user to her to be hospitalized twice since she has had to go out to doctor appointments and did not have any portable oxygen to take with her.Both times that she was hospitalized for about a week.No additional information provided.

• Brand Name: INVACARE HOMEFILL II OXYGEN COMPRESSOR 9153635497
• 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: 5754512
• MDR Text Key: 48300759
• Report Number: 1031452-2016-02856
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IOH200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2016
• 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): Hospitalization