FDA.reportPublic FDA data

MAUDE MDR 6186387

MDR report key
6186387
Report number
1824206-2016-00532
Event key
0
Event type
3
Date of event
2016-11-21
Date received
2016-12-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LORI DAULTON
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
1ENVISION BLOWER KITBED FLOTATION THERAPY POWEREDHILL-ROM BATESVILLEIOQP136026Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-12-1901. O

Event Narratives#

N

Patient 1

THE PRESSURE WOUND WAS TREATED WITH DAKINS SOLUTION AND ABDOMINAL PADS. DEVELOPMENT OF PRESSURE ULCERS IS MULTIFACTORIAL AND CANNOT BE ONLY ATTRIBUTED TO PERFORMANCE OF THE SURFACE. RISK FACTORS INCLUDE PROTEIN-CALORIE MALNUTRITION, MICROCLIMATE (SKIN WETNESS CAUSED BY SWEATING OR INCONTINENCE), DISEASES THAT REDUCE BLOOD FLOW TO THE SKIN, SUCH AS ARTERIOSCLEROSIS, OR DISEASES THAT REDUCE THE SENSATION IN THE SKIN, SUCH AS PARALYSIS OR NEUROPATHY. POSITION CHANGES ARE KEY TO PRESSURE SORE PREVENTION AND TREATMENT. THESE CHANGES NEED TO BE FREQUENT, REPOSITIONING NEEDS TO AVOID STRESS ON THE SKIN, AND BODY POSITIONS NEED TO MINIMIZE THE RISK OF PRESSURE ON VULNERABLE AREAS. THE BLOWER CONNECTION WAS NOT PROPERLY ATTACHED CAUSING THE BLOWER TO NOT FUNCTION AS DESIGNED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BLOWER IN AUGUST 2016. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BLOWER. THE TECHNICIAN PROPERLY CONNECTED THE BLOWER 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 PATIENT DEVELOPED A PRESSURE ULCER ON HIS SACRUM THAT PROGRESSED TO STAGE 4. THE BLOWER WAS LOCATED AT THE ACCOUNT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).