MAUDE Adverse Event Report: HILLROM INC HILLROM TOTALCARE BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/29/2018

Event Type  malfunction  

Event Description

The hospital bed began to spew hydraulic fluid out onto the floor.

• Brand Name: HILLROM TOTALCARE BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILLROM INC; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 7288536
• MDR Text Key: 100679329
• Report Number: 7288536
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/13/2018

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2018
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1