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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM, INC.; BED, FLOTATION THERAPY, POWERED
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HILL-ROM, INC.; BED, FLOTATION THERAPY, POWERED Back to Search Results
Model Number PR1900KM000084
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/14/2021
Event Type  malfunction  
Event Description
Covid-19 patient on continuous infusions.On admission, patient weight documented to be (b)(6).10 days later, this writer was processing pharmacy orders and noticed while verifying drip orders that current weight listed as (b)(6) which does not correspond with the known size of the patient.Pharmacist asked rn re: discrepancy and was informed that weight has not been correctly registered for several days due to broken bed scale and inability to transfer patient to working bed due to fragile oxygen status (covid).Propofol that was previously ordered was running at appropriate (b)(6) dosing weight in iv pump.Patient on other weight-based drugs cisatracurium, which require proper attention to selecting correct dosing weight for programming for which we are currently alerting each other via sign out alert but creates a work around situation for maintaining safe dose calculation for continued treatments, gfr calculations.
 
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Type of Device
BED, FLOTATION THERAPY, POWERED
Manufacturer (Section D)
HILL-ROM, INC.
1069 state route 46 east
batesville IN 47006
MDR Report Key11337258
MDR Text Key232184048
Report Number11337258
Device Sequence Number1
Product Code IOQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPR1900KM000084
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/21/2021
Event Location Hospital
Date Report to Manufacturer02/17/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/17/2021
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age16425 DA
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