COMPELLA P7800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for COMPELLA P7800 manufactured by Hill-rom, Inc..

Event Text Entries

[185053697] Head of bed was flat turned and the patient was on his on side to do wound care when staff saw a large spark and smoke. Bed was unplugged. Appropriate personnel were notified about electrical fire. Investigation showed that the magnetic clips that hold the electric cable in place had migrated, causing the cord to become frayed and broken, potentially causing the spark and smoke.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9882518
MDR Report Key9882518
Date Received2020-03-26
Date of Report2020-02-17
Date of Event2019-11-25
Report Date2020-02-18
Date Reported to FDA2020-02-18
Date Reported to Mfgr2020-03-26
Date Added to Maude2020-03-26
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
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
Generic NameBED, AC-POWERED ADJUSTABLE HOSPITAL
Product CodeFNL
Date Received2020-03-26
Returned To Mfg2020-02-18
Model NumberP7800
Device AvailabilityR
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 2020-03-26

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