MAUDE Adverse Event Report: HILL ROM VERSACARE BED

Model Number P3200K000613

Device Problem Fail-Safe Design Failure (1222)

Patient Problems Contusion (1787); Fall (1848); Head Injury (1879)

Event Date 01/07/2014

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014, a (b)(6) male inpatient taking anticoagulation medication, fell and hit his head on the floor which caused a potential serious injury.The fall was related to the height of the hill rom versacare bed.Upon admission on (b)(6) 2014, to the medical-surgical unit, the veteran's diagnosis was shortness of breath and exacerbation of congestive heart failure.He had been independent in activities of daily living at home.On (b)(6) 2014, the pt reached for his walker which set off the bed alarm.Pt was requesting to void.Nursing staff came to assist pt to stand at the edge of the bed using his walker for stability.This pt was independent, thus nursing staff was standing by while he was getting back into bed.The pt turned around facing the bed, and while climbing into the bed, his knee slipped off the bed.This caused the pt to fall, landing on his buttocks and then hitting the back of his head on the floor.Staff felt if the bed height was lower; the pt would not have to hoist himself into bed with his knee.A post fall head ct was completed and showed a potential subarachnoid hemorrhage and a small right frontal scalp contusion.New hill rom versacare beds were recently purchased.Since implementation, the height of the bed has been questioned as a significant factor impacting fall risk across the facility.The beds are 4 inches higher than the previous beds in place.The increase in bed height has been an ongoing pt safety issue.There were 3 near miss fall incidents and 2 falls (both resulting in minor injury) which may have been related to the increase in bed height before this incident.There have been 2 reported falls which may have been related to the bed since this incident (resulting in minor injury).The increased bed height has taken away pt independence, as pt's are no longer able to transfer themselves from bed to wheel chair.This is physically and psychologically taxing on pts as they try and cope with the loss of independence.Staff workload and physical stress has increased, as staff now have to assist pts into and out of bed to decrease the risk of fall related injuries.As of (b)(4) 2014, hill rom has been instructed to remove the bed casters and put new ones on.They have also been instructed to remove the motor (located under the bed-used to drive the bed).By these 2 items, the height of the bed will be reduced by 4 inches.

• Brand Name: HILL ROM VERSACARE BED
• Type of Device: BED
• MDR Report Key: 3653220
• MDR Text Key: 4201365
• Report Number: 3653220
• Device Sequence Number: 1
• Product Code: IOQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: P3200K000613
• Other Device ID Number: EE 25227
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/07/2014
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 96 YR
• Patient Weight: 85