FDA.reportPublic FDA data

MAUDE MDR 4004721

MDR report key
4004721
Report number
9710055-2014-00057
Event key
0
Event type
3
Date of event
2014-06-25
Date received
2014-07-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. JANICE PEVIDE
Address
45 BARBOUR POND DRIVE WAYNE NJ 07470 US
Phone
973-973-9737
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HANAULUX 3000NONEMAQUET S.A.SFSSHLX H4H5 DF VHM567823511NAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-07-2501. O

Event Narratives#

D

Patient 1

CUSTOMER REPORTED THAT THE SURGICAL LIGHT CUPOLA FELL OUT DURING A SURGERY, HITTING THE OPERATING ROOM NURSE. ACCORDING TO THE CUSTOMER, THERE WAS NO MAJOR INJURIES TO THE NURSE. NO PT HARM WAS REPORTED. (B)(4).

N

Patient 1

NOTE: THE NANAULUX 3000 SERIES LIGHT SYSTEM IS NOT MARKETED IN THE US. THIS REPORT HAS BEEN SUBMITTED DUE TO A SIMILARITY WITH DEVICES MARKETED BY MAQUET IN THE US. A MAQUET FIELD SERVICE TECHNICIAN (FST) EVALUATED THE DEVICE. HE DETERMINED THAT THE LIGHTHEAD FELL OF THE SPRING ARM BECAUSE THE SECURE SCREW WAS MISSING AND RETAINING RING PULLED UP. THE HANAULUX SERIES OPERATING MANUAL MENTIONS THAT THE PRODUCTS ARE TO BE INSPECTED BY A SPECIALISED TECHNICIAN EVERY SIX MONTHS. MAQUET IS NOT THE PRIMARY SERVICE PROVIDER OF THESE LIGHTS; THEY ARE MAINTAINED BY THE HOSPITAL BIOMEDICAL STAFF. THE DEVICE WAS REPAIRED BY THE FST AND CAN BE REUSED. MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.