FDA.reportPublic FDA data

MAUDE MDR 9803143

MDR report key
9803143
Report number
3006697241-2020-00013
Event key
0
Event type
3
Date of event
2020-02-23
Date received
2020-03-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LORI DAULTON
Address
1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US
Phone
812-812-8129
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADVANTA 2 FRAMEBED, AC-POWERED ADJUSTABLE HOSPITALHILL-ROM MEXICOFNLP1190A000027Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-060

Event Narratives#

N

Patient 1

THE HILLROM TECHNICIAN FOUND THE PATIENT HAND PENDANT NEEDED TO BE REPLACED. PER THE HILLROM SERVICE MANUAL THE ADVANTA? 2 SHOULD BE SUBJECT TO AN EFFECTIVE MAINTENANCE PROGRAM. TEST EACH OF THE BUTTONS TO CHECK THAT THEY ACTIVATE THE CORRECT FUNCTION AND THAT THEY DO NOT WORK INTERMITTENTLY BY PRESSING EACH BUTTON FOR SEVERAL SECONDS. EACH MOVEMENT MUST BE CONTINUOUS. REPLACE THE PENDANT IF NECESSARY. A SEARCH OF THE HILLROM MAINTENANCE RECORDS SHOWED HILLROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN FEBRUARY 2019. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE PATIENT HAND PENDANT TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

D

Patient 1

HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE HEAD OF THE BED WOULD RAISE ON ITS OWN (SELF RUN). THE BED WAS LOCATED IN THE WAREHOUSE AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).