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

Model Number P1900N

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/06/2016

Event Type  malfunction  

Event Description

The pt was in a hospital bed which would not maintain head elevation (i.E.Pt's head-of-bed (hob) was raised to a 30-degree angle but within a few minutes patient was noted to be lying flat).Note, the bed was at lowest level to the ground as it should have been to maintain hob elevation and still did not work.

• Brand Name: TOTALCARE
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; j34; batesville IN 47006
• MDR Report Key: 5825429
• MDR Text Key: 50529243
• Report Number: 5825429
• 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: 05/16/2016

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: Nurse
• Device Model Number: P1900N
• 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: 05/16/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 82 YR