MAUDE Adverse Event Report: HILL-ROM, INC 100 LOW; BED

Model Number P3930

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 04/03/2015

Event Type  malfunction  

Event Description

Resident had laceration on right leg.Possible cause was from frame of bed.

• Brand Name: 100 LOW
• Type of Device: BED
• Manufacturer (Section D): HILL-ROM, INC; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 5013191
• MDR Text Key: 23402271
• Report Number: 5013191
• 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: Biomedical Engineer
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: P3930
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2015
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2015
• 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
• Treatment: NO
• Patient Outcome(s): Other
• Patient Age: 92 YR