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U.S. Department of Health and Human Services

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

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HILL-ROM BATESVILLE TOTAL CARE FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number P1900G006252
Device Problem Entrapment of Device (1212)
Patient Problems Laceration(s) (1946); Foreign Body In Patient (2687)
Event Date 02/01/2023
Event Type  Injury  
Manufacturer Narrative
Baxter initially became aware an incident involving a totalcare bed being pulled toward the mri magnet in an article released on a media outlet.This evaluation addresses the injured nurse involved in this incident.It was noted the nurse was pinned against the hospital's mri device magnet by the icu bed and required surgical repair of multiple lacerations to her abdomen, mons, and left thigh, as well as surgical removal of two embedded screws.The following information represents a summary of the findings of the california department of public health complaint validation survey.Two hospital personnel (one registered nurse (rn) and one patient care technician) entered zone iii of the mr area with an intensive care patient (icu) on a ferromagnetic bed and were left unsupervised by mri personnel.Additionally, the two hospital personnel and patient were not screened prior to entering zone iii, in accordance with the hospitals policy and procedure regarding screening.The rn continued to move the patient in an icu bed into zone iv (area where magnet is located) without stopping in zone iii for a second screening and transferring the patient to a non-ferromagnetic bed/table.The entrance door to the magnetic room (zone iv) was also left opened.The mri safety alarm system, (called ferroguard, a wall mounted metal detector that provides a clear, simple, early warning of risk items approaching the magnet room, together with lowest audible alarm rates), located on either side of the entrance to zone iv (area where the magnet is located) did not function when the hospital bed was pulled through the entrance to zone iv.The bed pulled towards the magnet and the nurse became pinned against the magnet by the icu bed and patient fell to the floor but did not sustain any injuries.The mri technician did not quench (rapid expulsion of the liquid cryogen used to maintain the mri magnet in a superconducting state) the magnet during an emergency situation in accordance with the hospitals policy and procedure.According to the complaint validation survey, the many safety failures by the mri and non-mri personnel created a culture of unsafe practices leading to the severe injury of one hospital personnel and the potential for injury to one patient.The totalcare bed system is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure injury; or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.The totalcare® bed system is intended to provide a patient support to be used in health care environments.In this event, the surgical interventions required by the nurse (repair of multiple lacerations and removal of two embedded screws) are considered interventions completed to preclude permanent impairment of body function or permanent damage to a body structure, which concludes that a serious injury occurred.Additionally, there was no report of device malfunction.Based on the information available, the reported event can be contributed to the many safety failures identified by the above-mentioned california department of public health validation survey, including but not limited to, entering zone iv of the mr area without transferring the patient to a non-ferromagnetic bed/table, and not caused by the totalcare bed itself.
 
Event Description
Baxter initially became aware an incident involving a totalcare bed being pulled toward the mri magnet in an article released on a media outlet.This evaluation addresses the injured nurse involved in this incident.This report was filed in our complaint handling system as complaint # (b)(4).
 
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Brand Name
TOTAL CARE 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
kayla miller
1069 state route 46 east
batesville, IN 47006
8129310130
MDR Report Key18229172
MDR Text Key329264272
Report Number1824206-2023-01333
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962942
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 11/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model NumberP1900G006252
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
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