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 22D E manufactured by Carefusion.
[38490362]
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 device was not returned so no investigation could be done and no root cause could be determined. The device is currently working without issue. If more 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
[38490363]
The customer reported the isolation transformer started to spark and smell like smoke as if the system was burning. The system was not used after the reported incident. The customer's biomed took a look at the device and determined that the sparking was coming from the wall outlet and not associated with the pulmonary function testing (pft) system. The customer is now using the device without any issues. There was no harm or injury noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2016-03158 |
| MDR Report Key | 5429096 |
| Date Received | 2016-02-10 |
| Date of Report | 2013-07-01 |
| Date of Event | 2013-07-01 |
| Date Mfgr Received | 2013-07-01 |
| 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 | 22D E |
| 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 |