MAUDE MDR 195116

MDR report key: 195116
Report number: MW1014884
Event key: 0
Event type: 3
Date of event: 1998-10-05
Date received: 1998-11-04
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 500
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	HILL-ROM	BIRTHING BED	HILL-ROM, INC.	HHP	NI	NI	NI			N		Y

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	1998-11-04	0

Event Narratives#

D

Patient 1

ADDITIONAL INFO RECEIVED FROM MFR ON 12/17/98:NO SPECIFIED DEVICE LISTED IN THE REPORT EXCEPT AS BIRTHING BED. THE INFO PROVIDED IN THE REPORT DOES NOT CONTAIN: MODEL, SERIAL NUMBER, DATE OF MFR. NO SOURCE FROM WHICH HILL-ROM CAN OBTAIN INFO TO ADDRESS PROPOSED QUESTIONS.

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K963505	HHP	TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM	Tenet Medical Engineering	1997-02-14
510(k)	K822812	HHP	YSI MODEL 23L LACTATE ANALYZER	Yellow Springs Instrument Co., Inc.	1982-12-13

MAUDE MDR 195116

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

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