MAUDE MDR 477898

MDR report key: 477898
Report number: MW1029278
Event key: 0
Event type: 3
Date received: 2003-07-30
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
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	*	*	*	KGL	*	*	*			N		*

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2003-07-30	0

Event Narratives#

D

Patient 1

RPTR REC'D A CALL FROM SOMEONE AT A HOSPITAL REGARDING A "CLICKING" NOISE IN THEIR HAND/FOOT UNIT. THE DESCRIPTION OF THE NOISE SOUNDED JUST LIKE WHAT IS COMMON WITH THE FERRITE POT COURSE OF THE BALLAST OR THEY SNAP TOGETHER WHEN POWER IS APPLIED AND A MAGNETIC FIELD IS CREATED. THE CALLER WANTED TO KNOW IF THERE COULD BE ANY CHANCE OF A DANGEROUS SITUATION WITH A POTENTIAL SHOCK HAZARD TO EITHER THE PT OR THE OPERATOR. REPORTER ASSURED CALLER THAT THE MACHINE WAS THOROUGHLY GROUNDED AND THAT ANY SUCH RISK WAS VERY LOW, BUT IF THEY HAD ANY CONCERNS THEY SHOULD HAVE IT CHECKED BEFORE FURTHER USE. THEY WERE TO HAVE THEIR BIOMEDICAL PEOPLE CHECK THE MACHINE BEFORE FURTHER USE AND CALL BACK IF THEY FELT THERE WAS ANYTHING REQUIRING FURTHER ATTENTION. NO CALL WAS RECEIVED.

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K852575	KGL	WALDMANN F85/100W PUVA	Sylvania Lighting Products	1985-08-16
510(k)	K841795	KGL	UV 8001K, PUVA 800, PUVA 180/200 1000	Waldmann Lighting Co.	1984-08-30
510(k)	K820280	KGL	SPECTRA 305/350	Ultralite	1982-03-05
510(k)	K810668	KGL	HO-B-LITE VI UNIT	National Biological Corp.	1981-04-23
510(k)	K810358	KGL	PHOTOTHERAPY LIGHT CHAMBER	Paul B. Elder Co.	1981-03-20

MAUDE MDR 477898

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

Related PMN/PMA Records By Product Code#