COMPELLA BARIATRIC BED P7800A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-03 for COMPELLA BARIATRIC BED P7800A manufactured by Hill-rom, Inc..

Event Text Entries

[88073104]
Patient Sequence No: 1, Text Type: N, H10


[88073105] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6910498
MDR Report Key6910498
Date Received2017-10-03
Date of Report2017-09-29
Date of Event2017-04-01
Report Date2017-09-29
Date Reported to FDA2017-09-29
Date Reported to Mfgr2017-09-29
Date Added to Maude2017-10-03
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMPELLA BARIATRIC BED
Generic NameBED, FLOTATION THERAPY, POWERED
Product CodeIOQ
Date Received2017-10-03
Model NumberP7800A
Device AvailabilityY
Device Age1 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerHILL-ROM, INC.
Manufacturer Address1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006


Patients

Patient NumberTreatmentOutcomeDate
10 2017-10-03

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