FDA Adverse Event
Injury
Summary report: N
ATLAS VR
MDR report key: 1050985
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01919
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- March 6, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN
Additional Manufacturer Narrative · 1
THE REPORTED RESET ANOMALY COULD NOT BE REPRODUCED IN THE LABORATORY. UPON RECEIPT THE DEVICE WAS NOT IN RESET AND THERE WERE NO INDICATIONS OF A PAST RESET ANOMALY IN THE DEVICE'S DIAGNOSTICS. NO ANOMALIES WERE DETECTED DURING AUTOMATED AND BENCH TESTING.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS REMOVED DUE TO A RESET.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE VENTILATOR WENT VENT INOP WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE VENTILATOR WAS RETURNED TO THE FACTORY FOR EVALUATION. REVIEW OF THE VENTILATOR EVENT LOG CONFIRMED A VENT INOP DUE TO A PRESSURE SENSOR FAILURE DURING OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATLAS VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-199 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |