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

Model Number P7800A

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 04/01/2017

Event Type  malfunction  

Event Description

When the mattress topper is cleaned, the topper will overinflate and pop the surface, creating a ballooning effect.Manufacturer response for bariatric bed system, compella (per site reporter): mfg states ballooning is due to cleaning with blower motor running.

• Brand Name: COMPELLA BARIATRIC 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: 6910500
• MDR Text Key: 88073536
• Report Number: 6910500
• 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: 09/29/2017

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: Other
• Device Model Number: P7800A
• 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: 09/29/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2017
• Type of Device Usage: N
• Patient Sequence Number: 1