MAUDE Adverse Event Report: HILL-ROM, INC. VERSACARE P 3200; BED, FLOTATION THERAPY, POWERED

Model Number P3200

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Date 03/06/2016

Event Type  malfunction  

Event Description

Bed alarm was malfunctioning.Bed alarm was not loud enough to give adequate warning.Bed was not in use at the time it was removed.Clinical engineering reports speaker not working.

• Brand Name: VERSACARE P 3200
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 5513250
• MDR Text Key: 40746328
• Report Number: 5513250
• 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: Other
• Type of Report: Initial
• Report Date: 03/17/2016

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: P3200
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2016
• 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