MAUDE Adverse Event Report: HILL-ROM, INC. 300 WOUND SURFACE; BED, FLOTATION THERAPY, POWERED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 12/09/2017

Event Type  malfunction  

Event Description

The visitor tripped on the air mattress hose at the right foot of patient's bed.Loud noise was heard and then a cry for help.The visitor found on her hands and knees.Bleeding from bridge of nose and left hand.Pain in left prosthetic knee and right shoulder with arm movement.Patient hit her face on patient's wheelchair when she tripped.Band aid applied to bridge of nose and 2 areas on left hand with abrasions as she was bleeding.Assisted into wheelchair by nursing staff and transported to ed for evaluation.

• Brand Name: 300 WOUND SURFACE
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 7120443
• MDR Text Key: 94956838
• Report Number: 7120443
• Device Sequence Number: 1
• Product Code: IOQ
• 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: 12/14/2017

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other