MAUDE Adverse Event Report: HILL-ROM, INC. TOTALCARE SPO2RT; BED, FLOTATION THERAPY, POWERED

Model Number P1900E005297

Device Problems Unintended Head Motion (1284); Malposition of Device (2616)

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

Event Date 09/01/2016

Event Type  malfunction  

Event Description

Head of bed (hob) in wall did not remain elevated to 30 degrees, it is slowly lowering.Hob must be maintained at 30 degrees in order to meet ventilator bundle elements to prevent vap.

• Brand Name: TOTALCARE SPO2RT
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 6099463
• MDR Text Key: 59771070
• Report Number: 6099463
• 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: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: P1900E005297
• Other Device ID Number: CE00319
• 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: 09/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1