MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-24 for CARE-FUSION manufactured by Carefusion Respiratory Care.
[1638485]
Patient o2 levels and de-saturation occurring as the result of the equipment -care fusion-venturi mask devices #001255 - being incorrectly assembled for use in pt care. The issue was identified in the packaging which says "attention: see instructions for use" but there are no instructions in the packages. Company rep acknowledged that the instructions should have been in the packaging. Instructions were sent to mmc by the company. Product complaint submitted by company rep (b)(4). Respiratory therapy assessed all pts with this therapy currently in place to confirm correct assembly of each unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016517 |
| MDR Report Key | 1741388 |
| Date Received | 2010-06-24 |
| Date of Report | 2010-06-24 |
| Date Added to Maude | 2010-07-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARE-FUSION |
| Generic Name | CARE-FUSION VENTURI MASK DEVICES |
| Product Code | BYF |
| Date Received | 2010-06-24 |
| Lot Number | 001255 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION RESPIRATORY CARE |
| Manufacturer Address | 1450 WAUKEGAN ROAD MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-06-24 |