FDA.reportPublic FDA data

MAUDE MDR 8317190

MDR report key
8317190
Report number
1824206-2019-00054
Event key
0
Event type
3
Date of event
2019-01-25
Date received
2019-02-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
EMILY MITCHELL
Address
1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US
Phone
812-812-8129
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TC BARIATRIC PLUS W/ FOAMBARIATRIC BEDHILL-ROM BATESVILLEOSIP1840RE100Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-070

Event Narratives#

N

Patient 1

THE HILL-ROM TECHNICIAN FOUND THE BRAKE CASTERS NEEDED TO BE REPLACED. PER THE HILL-ROM SERVICE MANUAL, THE TOTALCARE? BARIATRIC BED AND TOTALCARE? BARIATRIC PLUS THERAPY SYSTEM REQUIRE AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM SEMI-ANNUAL PREVENTIVE MAINTENANCE (PM) FOR JOINT COMMISSION CERTIFICATION. PM NOT ONLY MEETS JOINT COMMISSION REQUIREMENTS BUT CAN HELP MAKE SURE A LONG, OPERATIVE LIFE FOR THE TOTALCARE? BARIATRIC BED AND TOTALCARE? BARIATRIC PLUS THERAPY SYSTEM. PM WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. INSPECT THE CASTERS FOR PROPER MOUNTING, EXCESSIVE WEAR, OR TREAD DAMAGE. REPLACE AS NEEDED. VERIFY PROPER OPERATION OF THE BRAKE SYSTEM. ADJUST AS NECESSARY. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN (B)(6) 2018. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE BRAKE CASTERS TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

D

Patient 1

HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BRAKES WERE NOT HOLDING. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).