FDA.reportPublic FDA data

MAUDE MDR 17354

MDR report key
17354
Report number
17354
Event key
0
Event type
3
Date of event
1994-02-17
Date received
1994-07-21
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#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BEARVENTILATORBEAR MEDICAL SYSTEMS INC.CBPBEAR 3NANANY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11994-07-2101. R

Event Narratives#

D

Patient 1

ON 2/17/94 WE LEARNED FROM THE HOSPITAL THAT A LOUD POP AND THEN HISSING SOUND WAS HEARD FROM THE VENTILATOR WHEN IT WAS BEING USED ON PATIENT. THE HOSPITAL TOLD US THAT THE PATIENT WAS "BAGGED" AND PLACED ON ANOTHER VENTILATOR, AND THE PATIENT WAS NOT INJURED.