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

Model Number XPO100B

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Device Stops Intermittently (1599)

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

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.

• Brand Name: XPO W/SUPPLEMENTAL BATTERY 9153648167
• 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: 5390162
• MDR Text Key: 36915368
• Report Number: 1031452-2016-00318
• 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,Followup
• Report Date: 02/23/2016

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: XPO100B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 01/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2016
• 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
• Patient Sequence Number: 1