MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS 50PSI COMPRESSOR MOBILAIRE 9153619938; COMPRESSOR, AIR, PORTABLE

Model Number XPO100B

Device Problem No Display/Image (1183)

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

Dealer is stating that the unit has a broken display.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.However, the device was evaluated and found to have a cracked/fractured rear cabinet, so the original complaint issue was not able to be confirmed.The product was returned for evaluation, but subsequent testing could not verify the complaint of a broken display.The rear shroud was identified as being fractured; however, the display is not positioned at that location of the device.Additionally, the battery was identified as not holding a charge, which could cause the front panel lights not to illuminate upon start up.This may have been the reason for the reported issue of a "broken" display, even though the display itself did not malfunction.

Event Description

Dealer is stating that the unit has a broken display.

• Brand Name: 50PSI COMPRESSOR MOBILAIRE 9153619938
• Type of Device: COMPRESSOR, AIR, 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: 5297230
• MDR Text Key: 34189531
• Report Number: 1031452-2015-17107
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 04/26/2016

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: 04/26/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2016
• 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