MAUDE Adverse Event Report: CAREMED SUPPLY, INC. RA 3000; BED, MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number FL2OE

Device Problems Collapse (1099); Difficult To Position (1467); Device Inoperable (1663); Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 07/01/2015

Event Type  malfunction  

Event Description

The bed does not allow you to move the feet up or down.When the lower railings are put up, the bed goes with it.The bed position buttons on front of bed do not work.The bed was deflated in center as well.

• Brand Name: RA 3000
• Type of Device: BED, MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): CAREMED SUPPLY, INC.; 4025 tampa rd., fl 1117; oldsmar FL 34677
• MDR Report Key: 5052795
• MDR Text Key: 24911534
• Report Number: 5052795
• 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: User Facility
• Reporter Occupation: Other
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: FL2OE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR