• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM BATESVILLE VERSACARE FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HILL-ROM BATESVILLE VERSACARE FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number P3200
Device Problem No Audible Alarm (1019)
Patient Problems Stroke/CVA (1770); Laceration(s) (1946)
Event Date 07/06/2023
Event Type  Injury  
Event Description
The customer¿s quality and patient safety specialist reported the bed exit alarm on an unknown bed was alarming in the patient¿s room but did not alert at the nurse¿s station through the baxter navicare nurse call system (addressed under internal reference (b)(4)).The patient fell and reportedly sustained a head laceration that led to a hemorrhage which led to a stroke.This report was filed in our complaint handling system as complaint # (b)(4).
 
Manufacturer Narrative
The customer¿s quality and patient safety specialist reported the bed exit alarm on an unknown bed was alarming in the patient¿s room but did not alert at the nurse¿s station through the baxter navicare nurse call system (addressed under internal reference (b)(6)).The patient fell and reportedly sustained a head laceration that led to a hemorrhage which led to a stroke.The patient is an 89-year-old male with an admitting diagnosis of atrial fibrillation and delirium management, and medical history of stroke, coronary artery disease, hypertension, and pneumonia.The reported patient fall occurred on (b)(6) 2023 sometime prior to 02:37 when the nurse found the patient.Nursing assessment showed stable vital signs and no neurological findings, and the head laceration was treated with a wound dressing.That same day, a ct scan at 03:33 showed a subarachnoid hemorrhage.The patient was started on praxbind intravenous (iv), and dabigatran was held.On (b)(6) 2023, a repeat ct scan showed no new findings.On (b)(6) 2023, assessment of the patient found left sided weakness and delayed response to commands.A ct scan was consistent with a subacute stroke.The patient was transferred to the stroke unit where recovery was slow.Per the customer, the patient had a stroke due to being off anticoagulants and the family did not pursue ¿criticall¿ for neurosurgical intervention.The patient was out of the window for tissue plasminogen activator (tpa) or endovascular thrombectomy (evt) and was not a candidate for tpa due to recent subarachnoid hemorrhage or evt (no salvageable tissue).The patient was started on aspirin 81mg and deep vein thrombosis (dvt) prophylaxis.On (b)(6) 2023, dabigatran was restarted.On (b)(6), a ct scan showed head stability, mild dehydration, prolonged delirium showing mild improvement day by day.On (b)(6) 2023, the patient was discharged to a retirement home in stable condition.The customer believes the nurse call cable was not plugged into the wall, which was why the bed alarmed locally in the room but not at the nurse¿s station.It was unknown if the bed had been removed from the room prior to the event and later returned without reconnecting the nurse call cable.The bed was not logged as defective; therefore, no further investigation could be performed and the bed in the room was replaced.Per the customer, the bed did not show offline as the nurse call cable was unplugged.The power cord for the bed was plugged in, and the bed exit alarm was activated on the bed.The customer stated the nurse call cables sometimes do not get plugged into the walls when the beds are moved around.The patient safety team is following up with training to staff on why this needs to be completed every time.Per the baxter account executive, the customer uses baxter versacare and centrella beds.As the bed was not isolated by the customer at the time of the event, baxter could not perform an inspection or confirm if an issue existed with the nurse call cable.However, the nurse call system was tested in the room where the event occurred, and the system functioned as designed.A missing screw was noted from the audio station bed connector (asbc) and was replaced.There was no loss of function of the asbc.A review of the versacare ifu includes the following warning: warning: a communication cable must be used for beds that have nurse call.Failure to do so could cause patient injury.For beds that have nurse call systems, a communication cable must be connected between the bed and facility communication system.A review of the centrella bed instructions for use (ifu) states when the bed exit alert system is armed and detects an alert condition, an audible alert comes on and a priority nurse call is sent to the nurse¿s station (for beds equipped and connected to a nurse call communication system).A laceration is a disruption of the skin, commonly called a cut and can have clean straight edges or jagged edges.A subarachnoid hemorrhage is bleeding in the space between the brain and surrounding membrane (subarachnoid space) that can occur from trauma or other blood vessel or health problems.The subacute stroke phase is a post-stroke period when the brain adjusts to the damage from a stroke.In this event, the patient required medical intervention (transfer to higher level of care, treatment for hemorrhage and stroke) to preclude permanent impairment of body function or permanent damage to a body structure, which concludes a serious injury occurred.The ultimate cause of the event is undetermined, but the customer believed the nurse call cable was not plugged into the wall.However, due to the bed not being isolated for inspection, it cannot be confirmed if the bed malfunctioned, or a use error occurred.If the reported event were to recur, it would be likely to cause or contribute to death or serious injury.Prevention of this type of event is outlined in the device ifu.Per the customer, the bed provided an audible alert locally in the room to notify the care team of patient movement.Additionally, the customer¿s patient safety team is conducting staff training on ensuring the nurse call cable is plugged in after a bed has been moved.Based on this information, no further action is required.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VERSACARE 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
maritza valencia
1069 state route 46 east
batesville, IN 47006
8129310130
MDR Report Key18003710
MDR Text Key326488688
Report Number1824206-2023-01202
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 10/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model NumberP3200
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/26/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age89 YR
Patient SexMale
-
-