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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS XPO W/SUPPLEMENTAL BATTERY 9153648167 GENERATOR, OXYGEN, PORTABLE

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INVACARE FLORIDA OPERATIONS XPO W/SUPPLEMENTAL BATTERY 9153648167 GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number XPO100B
Device Problems Display; Break
Event Type  Malfunction  
Manufacturer Narrative

Product has not been returned for evaluation as of the date of this investigation. Rma was issued. If new information becomes available at a later date, this complaint will be updated &/or a follow up be sent.

 
Event Description

Dealer is stating that the display is broken.

 
Manufacturer Narrative

Product was returned for evaluation. The return fields in oracle state: portable concentrators. Controls, switch/button broken. Complaint was confirmed. The underlying cause could not be determined after reviewing the documentation in this investigation.

 
Event Description

Product was returned for evaluation. The return fields in oracle state: portable concentrators. Controls, switch/button broken. Dealer is stating that the display is broken.

 
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Brand NameXPO W/SUPPLEMENTAL BATTERY 9153648167
Type of DeviceGENERATOR, 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 Key5346528
Report Number1031452-2016-00016
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Followup
Report Date 01/29/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/06/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberXPO100B
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/29/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2016
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

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