MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-11 for STATIC AND DYNAMIC COMPLIANCE 22 E 777404-101 manufactured by Carefusion.
[31132257]
Carefusion file identification: (b)(4). Patient demographics such as age, date of birth, gender, and weight were not provided by the customer. The carefusion field service engineer (fse) went on site to adjust co2 analyzer but the system still would not calibrate. The fse came back and installed a new vmax encore 22 system at the customer? S facility and performed system verification. The new unit conformed to the manufacturer? S published performance specifications and was returned to normal operation. Carefusion continues to track and trend any incident related to this issue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[31132258]
The customer reported having high frc during patient testing on the vmax encore 22 system; the customer has not performed a gas calibration before. The incorrect results were released to the physician; however the physician noticed the incorrect results. There was no report of patient impact associated with this event. The carefusion technical support (ts) explained to the customer on how to perform gas calibration and noted it failed twice after completing. The ts completed a diagnostic test on the unit and noted that the co2 baseline was high and did not increase to 1. 6 volts. A carefusion field service engineer was scheduled to inspect the unit at the customer's facility and the customer will ordered a new replacement module.
Patient Sequence No: 1, Text Type: D, B5
[32591002]
Failure analysis evaluation of the returned material: visual examination of the vmax module as received revealed no anomalies and physical damage. Testing of the unit continued by powering up the unit, and allowed to warm-up for 30 minutes. After 30 minutes, n2 calibration was performed, however the unit continued to fail. The c02 analyzer measured slope is < 0. 5 or greater than 1. 5. The slope on the lamp was too high. Investigation concludes that the co2 analyzer was determined to be faulty. The faulty c02 analyzer was replaced which resolved the reported issue. In conclusion, the likely cause of the event is attributed to the co2 analyzer. 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 | 2021710-2015-02177 |
| MDR Report Key | 5219018 |
| Date Received | 2015-11-11 |
| Date of Report | 2015-10-20 |
| Date of Event | 2015-10-20 |
| Date Mfgr Received | 2015-10-20 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2015-11-11 |
| 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 | 2015-11-11 |
| Model Number | 22 E |
| Catalog Number | 777404-101 |
| 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 | 2015-11-11 |