MAUDE Adverse Event Report: INVACARE CORP. MICROAIR; MATTRESS, AIR FLOTATION

Device Problem Failure to Power Up (1476)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Caller reported that her friend's mattress does not power up and is completely deflated.

• Brand Name: MICROAIR
• Type of Device: MATTRESS, AIR FLOTATION
• Manufacturer (Section D): INVACARE CORP.
• MDR Report Key: 6906741
• MDR Text Key: 87990739
• Report Number: MW5072542
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/29/2017

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: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR