MAUDE Adverse Event Report: HILL-ROM, INC. VERSACARE; BED, FLOATATION THERAPY, POWERED

Device Problem Improper Device Output (2953)

Patient Problem No Information (3190)

Event Date 05/02/2015

Event Type  malfunction  

Event Description

Bedscale weight was inaccurate when repeated weights taken.When the charge rn was checking the patient's daily weight values, it noted a 4 lb weight gain from yesterday's weight.When day shift na re-weighed patient, it showed a further increase in weight by 4lbs two hours later.The bed was switched out and work order placed.

• Brand Name: VERSACARE
• Type of Device: BED, FLOATATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; j34; batesville IN 47006
• MDR Report Key: 4780453
• MDR Text Key: 16991172
• Report Number: 4780453
• 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
• Type of Report: Initial
• Report Date: 05/04/2015

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: Nurse
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2015
• Patient Sequence Number: 1