MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-10 for STATIC AND DYNAMIC COMPLIANCE 22 E 777404-101 manufactured by Carefusion.
[38477215]
This mdr is being submitted in response to a two year retrospective complaint review that was performed by carefusion to identify mdr's following the issuance of a 483. The carefusion identification file is (b)(4). The device was evaluated by a carefusion factory service technician and the reported issue was duplicated. It was unable to perform a dlco calibration test. Also, he noticed that a burning smell was coming from the analyzer control board and the part was sent to the failure analysis lab for further investigation. If more information becomes available a follow up will be submitted. A replacement module was sent to the customer and installed successfully by a fse. Carefusion continues to track and trend any incident related to this issue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[38477216]
The customer reported getting a multi-gas sensor calibration out of range warning during a lung diffusion carbon monoxide (dlco) gas calibration and was unable to test patients. A carefusion field service engineer (fse) went on-site to repair the device and while replacing the sample pump he noticed a charring of the analyzer control board and a burning smell coming from the module. The device was returned to carefusion for an evaluation. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2016-03149 |
| MDR Report Key | 5428610 |
| Date Received | 2016-02-10 |
| Date of Report | 2015-04-21 |
| Date of Event | 2015-04-21 |
| Date Mfgr Received | 2015-04-27 |
| Date Added to Maude | 2016-02-10 |
| 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 | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 75 NORTH 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 | 0 |
| Brand Name | STATIC AND DYNAMIC COMPLIANCE |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2016-02-10 |
| Returned To Mfg | 2015-05-08 |
| Model Number | 22 E |
| Catalog Number | 777404-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2016-02-10 |