MAUDE Adverse Event Report: HILL-ROM, INC. VERSACARE; HOSPITAL, BED, ALARM

Model Number P3200

Device Problems Device Alarm System (1012); Material Frayed (1262)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/21/2018

Event Type  Injury  

Event Description

Housekeeper found patient lying on her back with knees bent on the floor in the patient's room.Housekeeper notified rn staff, patient assessed and denied pain.While attending to the patient after this event, patient returned to bed.Physician ordered ct of head and spine.Patient sustained a fracture.Bed was looked at by our clinical engineering team.During this assessment, a frayed communication cord was found.He was successful in setting the bed alarm in all three sensitivity settings.When he tried to silence it on one of the keypads, it did not silence but did alarm.

• Brand Name: VERSACARE
• Type of Device: HOSPITAL, BED, ALARM
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 8109823
• MDR Text Key: 128563291
• Report Number: 8109823
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/26/2018

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: P3200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31755 DA
• Patient Weight: 52