MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS CONC.DEMO UNIT F/IOH2SHOW HFII; GENERATOR, OXYGEN, PORTABLE

Model Number IRC5PO2V

Device Problems Device Alarm System (1012); Device Stops Intermittently (1599)

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

Event Type  malfunction  

Event Description

The dealer states that the unit is shutting down, the dealer is not aware of any alarms going off.

Manufacturer Narrative

(b)(4).The device was evaluated by the returns department which found that the 4-way valve is not shifting fully and the capacitor is leaking.

Event Description

The dealer states that the unit is shutting down, the dealer is not aware of any alarms going off.

Manufacturer Narrative

Should additional information become available for the patient a supplemental record will be filed.

• Brand Name: CONC.DEMO UNIT F/IOH2SHOW HFII
• 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: 4819173
• MDR Text Key: 15965987
• Report Number: 1031452-2015-14131
• 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,Followup
• Report Date: 06/16/2015

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: 06/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 06/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2015
• 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