FDA.reportPublic FDA data

MAUDE MDR 2781990

MDR report key
2781990
Report number
2531468-2012-00002
Event key
0
Event type
3
Date of event
2012-04-26
Date received
2012-09-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
513 S. CLEWELL ST BETHLEHEM PA 18015 US
Phone
610-610-6106
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HOVERMATT LATERAL PATIENT TRANSFER DEVICEDEVICE, PATIENT TRANSFER POWEREDD.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INTERNATIONALFRZHM34HSHM34HSNAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-09-1801. H

Event Narratives#

D

Patient 1

(B)(6) WAS DROPPED TO THE FLOOR WHILE BEING TRANSFERRED FROM HOSPITAL BED TO X-RAY TABLE 3 DAYS AFTER HAVING BILATERAL HIP REPLACEMENT. COULD HAVE BEEN OPERATOR ERROR OR EQUIPMENT FAILURE. DAMAGE TO LEFT HIP RESULTING IN BEING IN HOSPITAL A MONTH LONGER THAN EXPECTED, AND NEEDING TWO EXTRA OPERATIONS." THE EQUIPMENT FAILURE MENTIONED ABOVE IS THAT OF THE HOSPITAL BED BRAKES.

N

Patient 1

AS STATED IN THE REPORT FROM (B)(6): "AFTER THE INITIAL INVESTIGATION IT APPEARS THAT EITHER PROPER PT TRANSFER PROTOCOLS WHICH REQUIRE HOSPITAL BED BRAKES TO BE APPLIED BEFORE A TRANSFER COMMENCES WERE NOT ADHERED TO, OR THAT THE BRAKES ON THE BED WERE FAULTY." IT ALSO STATES IN THE HOVERMATT INSTRUCTIONS FOR USE; "ENSURE THE TRANSFER SURFACES ARE AS CLOSE AS POSSIBLE, AND BRAKE THE WHEELS." CONCLUSION: IT WOULD APPEAR THAT EITHER PROPER PT TRANSFER PROTOCOLS WHICH REQUIRE THE HOSPITAL BED BRAKES TO BE APPLIED BEFORE A TRANSFER COMMENCES WERE NOT ADHERED TO, OR THAT THE BRAKES ON THE BED WERE FAULTY. MY INVESTIGATION ALSO FOUND THAT THE HOVERMATT WAS OPERATING CORRECTLY AT THE TIME OF THE INCIDENT AND WAS INFLATED FIRMLY THOUGH TO SUPPORT THE PT AS THEY FELL. IT WAS ALSO SAID THAT THE HOVERMATT HAD IN FACT SAVED THE PATENT FROM RECEIVING A MUCH WORSE INJURY. IF THE PT HAD BEEN ON ANY OTHER TRANSFER DEVICE, THEY WOULD HAVE FALLEN DIRECTLY ONTO THE FLOOR.