MAUDE Adverse Event Report: HILLROM DE MEXICO S DE RL DE CV CAREASSISTED; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number 1170

Device Problem Device Alarm System (1012)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 12/04/2014

Event Type  Injury  

Event Description

Hill-rom received a report from the account stating the bed exit was set and a pt fell from the bed.The pt sustained a broken shoulder and arm for which she required surgery and was prescribed rehabilitation.The bed was located in room 3401 at the account.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The hill-rom technician thoroughly inspected the bed and found all bed exit and scale functions working properly.He tested the scale system and inspected for damaged or loose wiring but found the bed in proper working order.Per the hill-rom service manual the bed should be subject to an effective maintenance program.An annual service of the bed is advised in order to maintain its characteristics and performance.Every five years, the bed exit tapes switches should be replaced by a facility-authorized maintenance personnel.Ensure the bed exit system works properly.Replace worn or defective parts as needed.Per the hill-rom user manual, warning: the bed exit alarm system is not intended as a substitute for good nursing practices.The bed exit alarm system must be used in conjunction with a sound risk assessment and protocol.The injury is considered to be serious in nature as surgery was required in order to preclude permanent impairment.There was no evidence of a malfunction and the device performed as intended.

• Brand Name: CAREASSISTED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILLROM DE MEXICO S DE RL DE CV; apodaca ; MX
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 4380096
• MDR Text Key: 15108712
• Report Number: 3006697241-2015-00001
• 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: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 1170
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR