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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 Device Alarm System; No Audible Alarm; Device Stops Intermittently
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Consumer states the unit runs a little bit and then the red alarm light comes on and the lights 3 and 4 come on as well, no audible beep alarm. Consumer states intermittenly it will not turn on unless the charger is plugged in.

 
Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation. The result of the evaluation was that the manifold was leaking where the plastic meets metal, and the sieve caps were leaking causing the sieve beds to be saturated, causing the 3/4 alarm, which confirmed the original complaint issue. However, there was no indication of a failure of the audible alarm to operate. Additionally, the battery had a dead cell causing it not to charge, verifying the complaint of the unit not turning on unless the charger was plugged in.

 
Event Description

Consumer states the unit runs a little bit and then the red alarm light comes on and the lights 3 and 4 come on as well, no audible beep alarm. Consumer states intermittenly it will not turn on unless the charger is plugged in.

 
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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 Key5390162
Report Number1031452-2016-00318
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Reporter Occupation PATIENT
Type of Report Followup
Report Date 02/23/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/26/2016
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 Manufacturer02/23/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2016
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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