MAUDE Adverse Event Report: HILL-ROM BATESVILLE VC P500 NSC AIR RENTAL FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P3200HRENT03

Device Problem Defective Alarm (1014)

Patient Problems Hemorrhage, Subdural (1894); Hip Fracture (2349)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

The hillrom technician performed a visual check and found no signs of damage on the bed.A bed exit test was performed and found the scale was not set to zero, and would not set properly.This incident would be obvious to the user and be considered a use error.The rn did not zero the bed therefore, the alarm will not set as indicated in the user manual.After the scale was rezeroed the bed exit worked properly as intended.Per the hillrom user manual: zeroing the scale: the bed must be zeroed before the patient is put on the bed.Be sure to put all linens, pillows, and equipment on the bed before zeroing.To activate: press the enable control.Press and hold the zero control until 00.0 is shown (hold will be displayed until 00.0 is displayed), and then release the control.Note: after releasing the zero control, the scale display will show calc.Do not touch the bed until the display stops flashing calc and shows 0.0.The maximum displayed weight of 500 lb (227 kg) will be reduced if more than 20 lb (9 kg) of equipment is zeroed on the bed.If 50 lb (22.7 kg) is on the bed when zeroed, the maximum displayed weight will be 450 lb (204.1 kg).The scale display will blink the bed weight when the maximum weight is exceeded.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in sept 2019.It is unknown if the facility performed any other preventative maintenance on this bed.Based on this information, no further action is required.

Event Description

The customer stated that the bed exit did not alarm and the patient fell out of bed, sustaining a hip fracture and subdural hematoma.Upon speaking to the customer, the customer stated that they recognized a visual flashing wrench light on while caring for the patient.A wrench light is an indicator to the user that service is required and flashes to indicate a bed malfunction.A hip fracture is a break in the upper quarter of the femur (thigh) bone.The extent of the break depends on the forces that are involved.Treatment for hip fractures usually involves a combination of surgery, rehabilitation and medication.The type of surgery used is primarily based on the bones and soft tissues affected or on the level of the fracture.Although details regarding the patient and treatment for the hip fracture was not provided, surgery is almost always required and therefore meets the definition of a serious injury.Subdural hematoma is a type of bleeding in which a collection of blood¿usually associated with a traumatic brain injury¿gathers between the inner layer of the dura mater and the arachnoid mater of the meninges surrounding the brain.Although details regarding the patient and treatment for the subdural hematoma was not provided, surgery is almost always required for severe cases and therefore meets the definition of a serious injury.

• Brand Name: VC P500 NSC AIR RENTAL FRAME
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: beth graceffa ; 1069 state route 46 east; batesville, IN 47006 ; 3122337700
• MDR Report Key: 10105705
• MDR Text Key: 193326731
• Report Number: 1824206-2020-00233
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: P3200HRENT03
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2009
• 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): Required Intervention