MAUDE MDR 320037

MDR report key: 320037
Report number: 2020364-2001-00001
Event key: 0
Event type: 3
Date of event: 2001-02-01
Date received: 2001-03-09
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 1
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Contact: BRIAN FARIAS
Address: 10 BOWMAN DRIVE KEENE NH 03431 US
Phone: 603-603-6033
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE	ESOPHAGEAL STETHOSCOPE	SIMS PORTEX INC.	BZW	NA	ES400-12, ES400-18, ES400-24	1382			N	R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2001-03-09	0

Event Narratives#

D

Patient 1

AN ESOPHAGEAL STETHOSCOPE WAS USED DURING SURGERY. ONE DAY POST-OP, THE PT ALLEGEDLY COUGHED UP THE BALLOON THAT WAS ATTACHED TO THE DISTAL END OF THE ESOPHAGEAL STETHOSCOPE. THE HOSPITAL STAFF WERE REPORTEDLY UNAWARE OF ANY PROBLEMS PRIOR THE PT COUGHING UP THE BALLOON.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
30695085000734	Level 1	ICU MEDICAL, INC.	BZW	2016-10-14
10695085000730	Level 1	SMITHS MEDICAL MD, INC.	BZW	2016-10-14

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K874519	BZW	MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR	Mon-A-Therm, Inc.	1988-01-29
510(k)	K860558	BZW	ESOPHAGEAL STETHOSCOPE	Sharn, Inc.	1986-04-01
510(k)	K844444	BZW	ESOPHAGEAL STETHOSCOPE	Medical Parameters, Inc.	1985-01-10
510(k)	K843070	BZW	ESOPHAGEAL STETHOSCOPES	Primrose Medical, Inc.	1984-08-24
510(k)	K841574	BZW	QUAZAR ESOPHAGEAL STETHOSCOPE	Axiom Medical, Inc.	1984-08-15

MAUDE MDR 320037

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

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