FDA.reportPublic FDA data

MAUDE MDR 20984

MDR report key
20984
Report number
20984
Event key
0
Event type
3
Date of event
1994-11-19
Date received
1995-02-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VENTILATORPURITAN-BENNETTCBP7200SP**

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11995-02-2301. R

Event Narratives#

D

Patient 1

VENTILATOR SUDDENLY WENT INTO SAFETY VALVE OPEN (SVO) WHILE IT WAS IN THE CMV MODE ON THE PATIENT. PATIENT WAS IMMEDIATELY BAGGED WHILE REPLACEMENT VENTILATOR WAS OBTAINED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.