FDA.reportPublic FDA data

MAUDE MDR 195980

MDR report key
195980
Report number
MW1014914
Event key
0
Event type
3
Date of event
1998-08-20
Date received
1998-11-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AFFINITY BEDBIRTHING BEDHILL-ROM, INC.HHP3600D07**NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11998-11-0901. O

Event Narratives#

D

Patient 1

ADDITIONAL INFO RECEIVED FROM THE MFR ON 12/26/1998: THE FOOT SECTION PERFORMED AS INTENDED WHEN LOCK WAS FULLY ENGAGED. NO DISCREPANCIES/ ABNORMALITIES WERE NOTICED WITH THE DEVICE DURING THE VISUAL INSPECTION. DURING THE INSPECTION OF THE DEVICE AT THE FACILITY (BY THE MFR TECHNICIAN), A MEMBER OF THE NURSING STAFF SUGGESTED THAT WHEN THEY OR THE HOUSEKEEPER WERE MAKING THE BEDS AND TRYING TO TUCK THE SHEETS UNDERNEATH THE FOOTPLATE, THEY WERE CONSTANTLY HITTING THE LATCH. IT WAS STATED TO THE TECHNICIAN THAT SHE BELIEVED THAT THIS COULD BE WHAT WAS POSSIBLY CAUSING THEM TO UNLATCH. THE UNIT WAS NOT RETURNED TO THE MFR, BUT WAS INSPECTED AT THE USER FACILITY. COULD NOT DUPLICATE OCCURRENCE WHEN LATCH WAS FULLY ENGAGED AND RETURNED TO SERVICE.