MAUDE Adverse Event Report: RECOVER CARE RC 1000 ULTRA WITH SCALE; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problem Mechanical Problem (1384)

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

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

After repositioning the patient, ra-3000 bed was set to lowest position when it made a loud popping noise and dropped approximately 6 inches.No injuries and the bed is still functional.Bed swapped out for another bed for safety.Manufacturer response for specialty bed, rc 1000 ultra with scale (per site reporter): unknown.We requested a new bed and one was delivered.

• Brand Name: RC 1000 ULTRA WITH SCALE
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): RECOVER CARE; 2100 design rd; arlington, TX 76014
• MDR Report Key: 5322308
• MDR Text Key: 34218965
• Report Number: 5322308
• Device Sequence Number: 1
• Product Code: FNL
• 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
• Type of Report: Initial
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR