FDA Adverse Event
Other
Summary report: N
RAPIDLAB 1265 BLOOD GAS SYSTEM
MDR report key: 1234676
·
Received November 14, 2008
Report
- Report Number
- 1217157-2008-00013
- Event Type
- Other
- Date Received
- November 14, 2008
- Date of Event
- October 3, 2008
- Report Date
- October 17, 2008
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.
- Product Code
- CHL
- PMA / PMN Number
- K031560
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FIELD SERVICE ENGINEER REPLACED THE TOUCHSCREEN ON THE INSTRUMENT. CUSTOMER REPORTED THAT AFTER THE TOUCHSCREEN WAS REPLACED THE INSTRUMENT APPEARED TO BE WORKING FOR SEVERAL DAYS AND THEY ARE SATISFIED THE INSTRUMENT IS NOW RUNNING PROPERLY.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT AN OPERATOR THOUGHT THEY ENTERED 37 DEGREE CELSIUS FOR PT TEMPERATURE CORRECTION WHEN RUNNING A SAMPLE. THE REPORT SHOWED THAT 27 DEGREE CELSIUS WAS ENTERED. CUSTOMER CLAIMS THAT TEMPERATURE ERROR WAS DUE TO A MALFUNCTIONING TOUCHSCREEN ON THE INSTRUMENT. ERRONEOUS RESULTS WERE SENT TO THE PHYSICIAN. HOWEVER, THE OPERATOR NOTICED THE ISSUE UPON VIEWING THE REPORT AND CONTACTED THE PHYSICIAN IMMEDIATELY. NO ACTION TO THE PT WAS TAKEN AS A RESULT OF THE REPORTED RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RAPIDLAB 1265 BLOOD GAS SYSTEM | RAPIDLAB 1265 | CHL | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD. | RL1265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |