MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-24 for STATIC AND DYNAMIC COMPLIANCE 22 E 777543-102 manufactured by Carefusion.
[32204310]
The field service engineer (fse) assessed the unit and noted the analyzer responded incorrectly to gas calibration and verified gas tank pressures. The fse discovered a faulty oxygen (o2) cell sensor and replaced the senor to resolve the reported issue. The fse then allowed the unit to warm up and re-verified all o2 responses returned to normal ranges. The fse performed a functional residual capacity (frc) calibration and it passed within specifications. An frc validation procedure was also performed and completed at 98% of target. The customer indicated the questioned device will not be returned to carefusion. The unit was returned to normal operation. No further issues were noted by the customer. (b)(4). In conclusion, the likely cause of the event is attributed to the o2 cell sensor. However, a definitive root cause is unknown with the available information. Carefusion continues to track and trend any incident related to this issue.
Patient Sequence No: 1, Text Type: N, H10
[32204311]
The customer reported gas calibration issue while using the vmax encore 22 pulmonary function analysis instrument. A patient was being tested at the time of the reported issue, and test results were generated and released to the physician. The customer then noticed the results were erroneous and informed the physician; the results were not used in making a diagnosis. The customer stated there was no patient impact associated with this event. A field service engineer (fse) was dispatched to assess instrument.
Patient Sequence No: 1, Text Type: D, B5
[35224303]
Additional information from field service: the field service engineer (fse) verified the issue with o2 cell - reading at 0. 100 with the pump on. The fse removed the faulty o2 cell and installed a new o2 cell. The fse allowed the unit to warm up then performed verifications - all o2 responses returned to normal. The fse performed functional residual capacity (frc) analyzer calibration and it passed multiple times. The fse performed frc validation procedure and it was 98% of target.
Patient Sequence No: 1, Text Type: N, H10
[44789716]
Device evaluation: an evaluation of the returned device was performed. Visual inspection of the received o2 analyzer assembly noted no issues. The service technician connected the o2 analyzer to a known good vmax test unit and noted the o2 reading did not change after o2 was supplied. The technician confirmed it failed the analyzer calibration per lung volumes test, per the manufacturing procedure. The reported issue was able to be duplicated. In conclusion, the likely cause of the event is attributed to the o2 analyzer assembly. However, a definitive root cause is unknown. Carefusion continues to track and trend any incident related to this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2015-02323 |
| MDR Report Key | 5248525 |
| Date Received | 2015-11-24 |
| Date of Report | 2015-11-02 |
| Date of Event | 2015-11-02 |
| Date Mfgr Received | 2016-02-15 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2015-11-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 75 N. FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | CAREFUSION |
| Manufacturer Street | 1100 BIRD CENTER DRIVE |
| Manufacturer City | PALM SPRINGS CA 92262 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92262 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STATIC AND DYNAMIC COMPLIANCE |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2015-11-24 |
| Model Number | 22 E |
| Catalog Number | 777543-102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-24 |