MAUDE Adverse Event Report: HILL-ROM DE MEXICO S DE RL DE CV ADVATA 2 BED; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number 1190

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Hip Fracture (2349); Fracture, Arm (2351)

Event Date 04/14/2014

Event Type  Other  

Event Description

The account reported that they had a patient fall and the patient was found on the floor.It is not known if the patient position module was active or not.The account stated the patient broke her hip and wrist in the fall.The bed was located in room 242 at the facility.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

A hill-rom representative called the account and spoke with the risk manager at the facility.The risk manager reported the patient was taken to surgery for the broken hip to be repaired and had a reduction of the fraction of the wrist.The patient had pre-existing conditions of a urinary track infection, compression fracture of the thoracic vertebrae, copd, hypertension, emphysema, nicotine addiction and anxiety.The patient's hospital stay was prolonged due to the injuries from the fall but she was unsure how much longer the patient was hospitalized.The reported injury is serious in nature per fda definition.There was no evidence of a malfunction and the device performed as intended.Based on this information, no further action is required.The technician performed the investigation and per the account, the patient exited the bed to go to the bathroom.The bed exit did not alarm at the bed or at the nurses' station.The patient fell down in the bathroom and sustained an injury.The nurse stated that she believes the bed exit was enabled.The technician inspected the bed and upon investigation, found that all bed functions and features function as designed.The accounts maintenance stated that all bed functions were operational at the time of the occurrence.Maintenance reported that they received three calls prior to occurrence stating the staff could not set the bed exit due to the fact that the staff was trying to set the bed exit with a patient not in the bed or the scale had been zeroed with a patient in the bed.The technician reports that all functions are operational and the scale system was within 1% tolerance, no repair was needed.

• Brand Name: ADVATA 2 BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM DE MEXICO S DE RL DE CV; apodaca ; MX
• Manufacturer Contact: jennifer morris ; 1069 state route 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3844677
• MDR Text Key: 17384105
• Report Number: 3006697241-2014-00465
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 1190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2014
• Date Device Manufactured: 02/01/2014
• 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): Hospitalization
• Patient Age: 81 YR
• Patient Weight: 56