FDA.reportPublic FDA data

MAUDE MDR 6777202

MDR report key
6777202
Report number
1824206-2017-00335
Event key
0
Event type
3
Date of event
2017-07-26
Date received
2017-08-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
306
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ERIN PADGETT
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
1300 WOUND SURFACEBED FLOTATION THERAPY POWEREDHILL-ROM BATESVILLEIOQP4937EAS1Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-090

Event Narratives#

N

Patient 1

THE HILL-ROM TECHNICIAN EVALUATED THE BED AND FOUND THE SNAPS ON THE CENTER CUSHIONS HAD BECOME UNSNAPPED. THE TECHNICIAN RECONNECTED THE SNAPS ON THE CENTER CUSHIONS TO RESOLVE THE ISSUE. THE PATIENT IS BEING TREATED WITH MUPIROCIN OINTMENT. THE PRESSURE SORE IS NEARLY HEALED AND THE PATIENT WILL BE SEEING THE WOUND CARE DOCTOR AGAIN NEXT WEEK. PER THE HILL-ROM SERVICE MANUAL, DURING THE INITIAL INFLATION OF MATTRESS WITH BOLSTER, THE INSTALLER SHOULD ADJUST THE BOLSTERS INTO THE PROPER LOCATION ON THE SURFACE. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

D

Patient 1

HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE PATIENT HAD SKIN BREAKDOWN DUE TO THE BLADDERS SHIFTING INSIDE THE MATTRESS. 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).