FDA.reportPublic FDA data

MAUDE MDR 6690145

MDR report key
6690145
Report number
1031452-2017-00049
Event key
0
Event type
3
Date of event
2017-06-07
Date received
2017-07-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
403
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR JASON FIEST
Address
ONE INVACARE WAY ELYRIA OH 44036 US
Phone
800-800-8003
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IVC BARIATRIC BED 9153641598AC POWERED BEDINVACARE FLORIDAOSINA:BAR600IVCBAR600IVCY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-060

Event Narratives#

N

Patient 1

THE BED HAS BEEN RETURNED AND AN EVALUATION IS IN PROCESS. THE FACILITY STATES THAT THE BED STARTED SMOKING WHILE THE PATIENT WAS IN THE BED, SO THEY UNPLUGGED IT. THEY LEFT THE PATIENT IN THE BED. THERE WERE NO INJURIES OR DAMAGE CAUSED BY THE BED. THE BED HAS BEEN REPLACED. WHEN THE RETURN EVALUATION HAS BEEN COMPLETED, A SUPPLEMENTAL RECORD WILL BE FILED.

D

Patient 1

THE DEALER STATED ACCORDING TO HIS CUSTOMER, THE JUNCTION BOX ON THE BED CAUGHT ON FIRE. NOTHING WAS DAMAGED AND NO ONE WAS INJURED.

N

Patient 1

AN EVALUATION OF THE RETURNED BED HAS BEEN COMPLETED. THE TESTING OF THE JUNCTION BOX CONFIRMED THAT TWO CAPACITORS SHORTED OUT, WHICH CAUSED SMOKE TO EMIT FROM THE BOX WHEN PRESSING THE HEAD UP/DOWN FUNCTIONS ON THE PENDANT. THIS ISSUE HAS BEEN ESCALATED TO OUR RISK DEPARTMENT. SHOULD FURTHER INFORMATION BE IDENTIFIED, A SUPPLEMENTAL RECORD WILL BE FILED.