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 229 E 777410-101 manufactured by Carefusion.
[38536140]
This mdr is being submitted in response to a two year retrospective complaint review that was performed by carefusion to identify mdrs following the issuance of a 483. The (b)(4). The malfunctioning computer was retired from service and the user facility information technology specialist will remove the old hard drive to destroy it and then the computer will be discarded under the user facility's supervision. The customer purchased an upgraded computer and it has been installed and is functioning as intended per the operator's manual. If additional information becomes available a follow up will be submitted. Carefusion continues to track and trend any incident related to this issue. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[38536141]
The customer reported a smell which he describes as hot like something within the computer is melting. Also, the display has become pixilated and the software is not responding appropriately during both functional residual capacity (frc) testing and lung diffusion capacity (dlco) testing. When the system is on for a length of time the odor is more noticeable and the staff noted that the room is hazy. Carefusion technical support technician recommended to turn off the computer immediately and unplug it from it's power source as it could pose a fire risk. The customer reported an irritation to the eyes while in the room but no medical attention was sought. The device will not be returning to carefusion for an evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2016-03150 |
| MDR Report Key | 5429144 |
| Date Received | 2016-02-10 |
| Date of Report | 2014-09-22 |
| Date of Event | 2014-09-22 |
| Date Mfgr Received | 2014-09-22 |
| 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 |
| Model Number | 229 E |
| Catalog Number | 777410-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 |