MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-05 for VITAL SIGNS LIMB-O SINGLE LIMB ANESTHESIA C-ASMXXXX manufactured by Carefusion/vyaire Medical, Inc..
[101838989]
Gas line sample port does not communicate with gas sample line. Hole in elbow is blocked. Dates of use: (b)(6) 2018. Is the product compounded: no. Is the product over-the-counter: no. Event abated after use stopped or dose reduced. Yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075680 |
| MDR Report Key | 7316799 |
| Date Received | 2018-03-05 |
| Date of Report | 2018-02-20 |
| Date of Event | 2018-02-02 |
| Date Added to Maude | 2018-03-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITAL SIGNS LIMB-O SINGLE LIMB ANESTHESIA |
| Generic Name | BREATHING CIRCUIT |
| Product Code | CAG |
| Date Received | 2018-03-05 |
| Model Number | C-ASMXXXX |
| Lot Number | 0001189444 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION/VYAIRE MEDICAL, INC. |
| Manufacturer Address | 26125 N. RIVERWOODS BLVD. METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-05 |