FDA.reportPublic FDA data

MAUDE MDR 8185431

MDR report key
8185431
Report number
3010216206-2018-00002
Event key
0
Event type
3
Date of event
2018-11-27
Date received
2018-12-20
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
MR. JOHN DRAHOS
Address
1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ALLEN LIFT ASSIST BEACH CHAIRBEACH CHAIRALLEN MEDICAL SYSTEMSCCXA-91501-A1Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-200

Event Narratives#

N

Patient 1

HILL-ROM'S INITIAL INVESTIGATION REVEALED THERE WAS INSUFFICIENT LOCTITE APPLIED WHERE THE TOP HYDRAULIC ASSEMBLY CONNECTS TO THE SUPPORTING TUBES OF THE BACKBOARD OF THE CHAIR. IF THIS JOINT LOSES CONNECTION, THE FORCE WOULD BE DIRECTED ONTO THE BACKBOARD OF THE CHAIR WHICH MAY CAUSE IT TO SHEER APART AS IT APPEARS OCCURRED IN THIS INCIDENT. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE CHAIR AT THIS TIME. HILL-ROM HAS INITIATED A CAPA TO FURTHER INVESTIGATE THIS INCIDENT AND THE INVESTIGATION IS ONGOING. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

D

Patient 1

HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BEACH CHAIR FELL BACK DURING A PROCEDURE. THE MOMENTUM WAS MINIMIZED BY A PUMP NEXT TO THE PATIENT AND A STAFF MEMBER WHO HELD THE CHAIR IN THE UPRIGHT POSITION THE SURGEON FINISHED THE PROCEDURE AND NO PATIENT/USER INJURY WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).