MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS XPO2 PORTABLE CONCENTRATOR 9153648166; GENERATOR, OXYGEN, PORTABLE

Model Number XPO110

Device Problem Battery Problem (2885)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Consumer states one of the two supplemental batteries she has has wires exposed.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.Two supplemental batteries were returned for evaluation, and subsequent testing verified the complaint.The underlying cause could not be determined after reviewing the documentation in this investigation.Per the initial evaluation, the first battery (serial number (b)(4)) would not hold a charge.An expanded evaluation was performed.Per the expanded evaluation report, there were no physical defects with the unit.However, when connected to a test concentrator, the battery only ran for 61 minutes on flow setting 5 before the battery was depleted, which is less than the target battery duration of ~80 minutes.The pcb was observed to be in good condition, and both the white and black wires had connectivity; however, a small nick was discovered in the insulation of the black wire.Per the initial evaluation, the second battery (serial number (b)(4)) had cord/wire damage, as the cord was pulled out.An expanded evaluation was performed.Per the expanded evaluation report, the strain relief had been severed and the insulation of the white positive wire was damaged.When connected to a test concentrator, the battery was not able to supply power.The pcb was observed to be in good condition, and the black wire had connectivity; however, there was no connectivity across the white wire.

Event Description

Consumer states one of the two supplemental batteries she has wires exposed.

• Brand Name: XPO2 PORTABLE CONCENTRATOR 9153648166
• 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: 5342972
• MDR Text Key: 35347502
• Report Number: 1031452-2015-17297
• 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 Family Member or Friend
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/18/2016

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: XPO110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 01/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2016
• 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