MAUDE Adverse Event Report: HILL-ROM,INC. TOTALCARE BED; BED, FLOTATION THERAPY, POWERED

Model Number P1900L006220

Device Problems Unintended Head Motion (1284); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/04/2016

Event Type  malfunction  

Event Description

Head of patient's bed would not remain at 30 degree angle or greater.Patient (who did not touch bed controls) was found lying flat within 15 minutes to one half hour after head of bed raised.Head of bed reset to 30 degrees multiple times throughout course of day with same end result.Bed height level was always set to lowest level.

• Brand Name: TOTALCARE BED
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM,INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 5825379
• MDR Text Key: 50528780
• Report Number: 5825379
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/20/2016

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: No Information
• Device Model Number: P1900L006220
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1