FDA.reportPublic FDA data

MAUDE MDR 3020

MDR report key
3020
Report number
3020
Event key
0
Event type
3
Date of event
1991-12-11
Date received
1992-08-19
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
1DISPOSABLE PEDIATRIC AMBU BAGMAPLESON-VITAL SIGNS, INC.KNE**

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11992-08-1901. O

Event Narratives#

D

Patient 1

PATIENT WAS MANUALLY BEING VENTILATED WITH VITAL SIGNS, INC. ANESTHESIA BAG. MANUAL VENTILATION WAS TO BE DECREASED. AS THIS WAS ADJUSTED THE RELIEF VALVE ON AMBU BAG FILLED WITH OXYGEN GAS. CHEST X-RAY PERFORMED. NO PATIENT INJURY DELETEDINVALID 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.