N
Patient 1
CAREFUSION FILE IDENTIFICATION NUMBER (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED BY CAREFUSION.
MAUDE MDR 5163546
- MDR report key
- 5163546
- Report number
- 2021710-2015-01932
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-08-06
- Date received
- 2015-10-21
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 114
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JILL RITTORNO
- Address
- 75 NORTH FAIRWAY DR. VERNON HILLS IL 60061 US
- Phone
- 262-262-2627
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PLETHYSMOGRAPH, PRESSURE | MASTERSCREEN PAED-BABY BODY | CAREFUSION | CCM | MS-BABY BODY TP | 001-175550 | R | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-10-21 | 0 | 1. O |
Event Narratives#
D
Patient 1
IT WAS REPORTED BY THE CUSTOMER THAT THE SHUTTER BALLOON TEST FAILED AND RECEIVED A "SHUTTER PRESSURE ZERO FAIL" MESSAGE AND THE DATA WAS LOST FOR THE PATIENT. AFTER TROUBLESHOOTING WITH FIELD SERVICE ENGINEER (FSE) IT IS UNKNOWN IF THE REPORTED ISSUE HAS BEEN CORRECTED. THE CUSTOMER STATED DUE TO THE EQUIPMENT BEING NON-OPERATIONAL THEY HAD TO PERFORM A MORE INVASIVE DIAGNOSTIC TEST (BRONCHOSCOPY) AND THE LOSS OF DATA FROM THE PULMONARY FUNCTION TEST CONTRIBUTED TO A DELAY IN THE PATIENT'S DIAGNOSIS.
N
Patient 1
A FUNCTIONAL CHECK WAS DONE BY A CAREFUSION FAILURE ANALYSIS TECHNICIAN. THE COMPUTER WAS BOOTED UP AND THE DEVICE MANAGER WAS ACCESSED. THE VIDEO CARD WAS RECOGNIZABLE TO THE SYSTEM. THERE WERE NO PROBLEMS FOUND ON THE VIDEO CARD AND THE VIDEO CARD IS FUNCTIONING PROPERLY. IN CONCLUSION, THE CUSTOMER?S COMPLAINT OF ?WINNOV CARD NOT BEING RECOGNIZED? AND SHUTTER PROBLEM COULD NOT BE CONFIRMED. FAILURE ANALYSIS INDICATED THERE WAS NO DAMAGE OR BURNT COMPONENTS ON VIDEO CARD AND THE OPERATIONAL/FUNCTIONAL CHECK WAS NORMAL. THERE WAS NO PROBLEM FOUND. AS A RESULT OF NOT BEING ABLE TO DUPLICATE THE CUSTOMER?S EXPERIENCE, A CONCLUSIVE ROOT CAUSE COULD NOT BE IDENTIFIED.
N
Patient 1
RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS LAB RECEIVED THE PAEDIATRIC PNEUMOTACH AND PERFORMED A FAILURE INVESTIGATION. THE DEVICE WORKED AS EXPECTED TO SERVICE SPECIFICATIONS AND THE FAILURE COULD NOT BE DUPLICATED. THE CAREFUSION FAILURE ANALYSIS LAB RECEIVED A SECOND COMPONENT TO EVALUATE, THE MS PAEDIATRIC HANDLE, AND AN INVESTIGATION WAS COMPLETED. IT WAS DETERMINED THAT THIS WAS THE WRONG COMPONENT FOR THE PRIMARY DEVICE. THE WRONG PART NUMBER WAS ORDERED FOR THE PRODUCT SO THE COMPONENT WAS INCOMPATIBLE FOR PROPER USAGE AND COULD NOT BE INSTALLED PROPERLY.
N
Patient 1
RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS LAB RECEIVED THE BOARD SSB AND PERFORMED A FAILURE INVESTIGATION. THE DEVICE WAS RECEIVED IN A DAMAGED CONDITION AND WHEN TESTED, THE COMPONENT WAS HOT AND NON-FUNCTIONING. NO FURTHER INVESTIGATION WAS POSSIBLE.
N
Patient 1
RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS LAB RECEIVED THE PRINT MSB48907 AND PERFORMED A FAILURE INVESTIGATION. THE DEVICE WORKED AS EXPECTED TO SERVICE SPECIFICATIONS AND THE FAILURE COULD NOT BE DUPLICATED. THE CAREFUSION FAILURE ANALYSIS LAB RECEIVED A SECOND PRINT MSB48907 AND AN INVESTIGATION WAS COMPLETED. THE DEVICE WORKED AS EXPECTED TO SERVICE SPECIFICATIONS AND THE FAILURE COULD NOT BE DUPLICATED.
N
Patient 1
RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS LAB RECEIVED THE MASTERSCREEN BABY BODY BOX AND PERFORMED A FAILURE INVESTIGATION. THE ROOT CAUSE OF THE ISSUE WAS FOUND TO BE INCORRECT ASSEMBLY OF THE DEVICE. THE WIRING OF V1 AND V2 WAS WRONG, THERE WAS A BAD SOLDERING POINT ON V2 AND THE SQUEEZE SENSORS HAD NO ELECTRICAL ALIGNMENT.