FDA.reportPublic FDA data

MAUDE MDR 9241

MDR report key
9241
Report number
9241
Event key
0
Event type
3
Date of event
1994-02-06
Date received
1994-07-29
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
1TELEMETRY MONITORING EQUIPMENTMARQUETTE ELECTRONICSGYES7500**

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11994-07-2901. O

Event Narratives#

D

Patient 1

THIS MONITOR HAD A RUN OF VENTRICULAR ECTOPY DISPLAYED ON THE SCREW. THERE WERE 7 TO 8 BEATS OF ECTOPY BUT NO AUDIBLE ALARM. PATIENT UNHARMED.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.