MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-30 for STATIC AND DYNAMIC COMPLIANCE 22 E manufactured by Carefusion.
[30330662]
Any additional information received from the customer will be provided in a follow-up report. (b)(4). Carefusion has not received the suspect device from the customer. Carefusion file identification: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[30330663]
The customer reported incomplete washout reaching and remaining at approximately 2% with and without balloons while performing pulmonary function analysis on a patient utilizing the vmax encore 22 instrument. Incorrect test results were generated and released to the physician. The customer then informed the physician of the incorrect results. The customer stated there was no patient impact associated with this event. Further system troubleshooting, with technical support, resulted in a replacement of the oxygen (o2) sensor but washout remained below 4%. The customer received a replacement unit and resumed pulmonary function analysis. No further issues were noted by the customer.
Patient Sequence No: 1, Text Type: D, B5
[35006843]
Additional manufacturing narrative: factory analysis of the returned module was performed. The module was connected to a vmax test station (vm-3) and allowed the unit to warm up for 30 minutes. The laboratory then performed acceptance test procedure (atp): lung volume test yielded at 4. 11b and functional residual capacity (frc) did not wash out; percentage (%) did not go below 4% and frc data spiked on the graph. The laboratory isolated the error to the oxygen (o2) sensor and carbon dioxide (co2) analyzer. In addition, it was noted the demand valve was slightly stiff. Power supply voltage was <15. 00, remained at 14. 71. The demand valve, power supply, o2 sensor, and co2 analyzer were replaced. Performance testing was performed, and the unit conformed to service specifications. In conclusion, the likely cause of the event is attributed to system software. 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
[46087373]
An evaluation of the co2 analyzer assembly device was performed. There was no visible external physical damage. The co2 analyzer was installed in the vmax encore 229 test unit and set to warm up (with the sample pump on) for 30 minutes. In the diagnostic test display, the ambient co2 reading was 0. 017v and with the sample pump on it was 0. 000v. With cal 1 gas on it went to 1. 838v meeting the minimum required co2 specification of 1. 6v. The exercise metabolic o2 and co2 analyzer calibration test was run several times and passed each time successfully. The lung volume n2 analyzer calibration test was run several times and passed each time successfully. The frc lung volume n2 wash test was performed three times and each time passed within specification (between 95% and 105% - meeting specification at 100% on average). The test was repeated and the results were similar. The complaint of the washout not falling below 4% was not duplicated. Carefusion continues to track and trend any incident related to this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2015-02087 |
| MDR Report Key | 5190203 |
| Date Received | 2015-10-30 |
| Date of Report | 2015-09-24 |
| Date of Event | 2015-09-24 |
| Date Mfgr Received | 2016-05-23 |
| Device Manufacturer Date | 2008-09-01 |
| Date Added to Maude | 2015-10-30 |
| 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 | 2015-10-30 |
| Returned To Mfg | 2015-11-18 |
| Model Number | 22 E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2015-10-30 |