FDA.reportPublic FDA data

MAUDE MDR 7921762

MDR report key
7921762
Report number
7921762
Event key
0
Event type
3
Date of event
2018-08-31
Date received
2018-10-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HOVERMATTDEVICE, PATIENT TRANSFER, POWEREDD.T. DAVIS ENTERPRISES LTD.FRZHM34HSHM34HS* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-10-010

Event Narratives#

D

Patient 1

NURSE SAID PATIENT NEEDED TO BE ON A STRETCHER AND SHOULD BE SLID OVER TO THE STRETCHER. TRANSPORTERS ROLLED PATIENT FROM SIDE TO SIDE TO PLACE THE REUSABLE HOVERMATT UNDER PATIENT. THE STRETCHER WAS PLACED ALONGSIDE THE BED. TRANSPORTERS INFLATED THE HOVERMATT AND SLOWLY SLID THE PATIENT OVER IN THE DIRECTION OF THE STRETCHER. WHILE SLIDING THE HOVERMATT OVER ON TO THE STRETCHER IT SEEMED TO MEET SOME RESISTANCE IN THE SOUND OF IT'S INFLATION AND THEN GAIN IT BACK. THE PATIENT WAS IN THE MIDDLE OF THE STRETCHER. TRANSPORTERS AGREED HE WAS SET ON THE STRETCHER AND MOVED TO TURN OFF CANISTER AND DEFLATE THE HOVERMATT. SUDDENLY THE PATIENT AND HOVERMATT STARTED MOVING TOWARD THE EDGE OF THE BED AND THE TOP HALF OF THE MATT WITH PATIENT SLID TO THE GROUND. PATIENTS FEET REMAINED ON THE STRETCHER. HOVERMATT REMAINED INFLATED AND PATIENT DENIES STRIKING HEAD OR ANY INJURY. HOVERMATT REMOVED FROM SERVICE.