FDA.reportPublic FDA data

MAUDE MDR 4449582

MDR report key
4449582
Report number
2531468-2014-00001
Event key
0
Event type
3
Date received
2014-12-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Address
513 S. CLEWELL ST. BETHLEHEM PA 18020 US
Phone
800-800-8004
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HOVERMATTDEVICE, PATIENT TRANSFER, POWERED.D.T. DAVIS ENTERPRISES LTD.FRZR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-12-220

Event Narratives#

D

Patient 1

REFERENCE UF/IMPORTER # (B)(4).

N

Patient 1

ON (B)(6) 2014, HOVERTECH'S QUALITY MANAGER LEARNED OF THE INCIDENT OF THE PATIENT FALLING OUT OF BED WITH INJURY. AT THIS TIME WE BELIEVED THIS TO BE A 30 DAY REPORT. MANUFACTURER WAS INFORMED OF THE STATUS OF THE PATIENT AT A MUCH LATER DATE. THE REPORT FROM (B)(6) WAS NOT RECEIVED UNTIL (B)(6) 2014. NO CAUSE OF DEATH WAS RECORDED. THE MANUFACTURER'S REPORT HAS BEEN SENT TO THE FDA WITHIN 5 DAYS OF BEING NOTIFIED OF THE PATIENT'S PASSING. THERE IS NO INFORMATION IN THE FACILITY REPORT THAT INDICATES THE UNINFLATED HOVERMATT (LATERAL TRANSFER DEVICE) CONTRIBUTED TO THE PATIENT FALL AND SUBSEQUENT INJURIES: THE LATERAL TRANSFER DEVICE WAS NOT IN USE WHEN THE INCIDENT OCCURRED.; THE PATIENT HAD BEEN SLEEPING ON THE UNINFLATED LATERAL TRANSFER DEVICE.; ONLY 3 OF THE 4 BED RAILS WERE EMPLOYED WHEN THE INCIDENT OCCURRED.; HOVERTECH'S INSTRUCTIONS FOR USE PROVIDED ACCORDING TO REGULATION ON THE EQUIPMENT AND IN THE USER'S MANUAL CLEARLY STATE THAT THE BED RAILS SHOULD BE RAISED AFTER THE HOVERMATT IS DEFLATED. WE ARE COORDINATING RETRAINING WITH THE FACILITY.