MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-14 for ARGYLE 8888301614 manufactured by Covidien Lp.
[91916279]
Patient Sequence No: 1, Text Type: N, H10
[91916280]
Suction tubing attached to anesthesia machine was not connected to suction canister before cases in or room, i reconnected it prior to start of day. Upon emergence of anesthesia for first patient, i tried to suction patient's orally and tubing was disconnected. Twice within few minutes or nurse had to reconnect tubing to canister as it fell twice during emergence. Tubing has to be pushed on and twisted and still can fall off elbow connection on canister.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7027661 |
| MDR Report Key | 7027661 |
| Date Received | 2017-11-14 |
| Date of Report | 2017-10-25 |
| Date of Event | 2017-09-14 |
| Report Date | 2017-10-25 |
| Date Reported to FDA | 2017-10-25 |
| Date Reported to Mfgr | 2017-10-25 |
| Date Added to Maude | 2017-11-14 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | ARGYLE |
| Generic Name | TUBING, NONINVASIVE |
| Product Code | GAZ |
| Date Received | 2017-11-14 |
| Model Number | 8888301614 |
| Catalog Number | 8888301614 |
| ID Number | 2310 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | KARIN DESJARDINS 15 HAMPSHIRE ST MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-14 |