MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-30 for GLIDESCOPE GLIDERITE 0270-0916 manufactured by Verathon Incorporated.
[103943316]
Patient Sequence No: 1, Text Type: N, H10
[103943317]
Toddler receiving active resuscitation in emergency department (ed). Respiratory therapist at the bedside preparing equipment for the ed physician to intubate the child. When inserting the stylet into the et (endotracheal) tube, the stylet reportedly broke in half. The equipment broke before it was used on the patient. It was removed and new equipment was obtained for intubation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7384936 |
| MDR Report Key | 7384936 |
| Date Received | 2018-03-30 |
| Date of Report | 2018-03-15 |
| Date of Event | 2018-02-15 |
| Report Date | 2018-03-15 |
| Date Reported to FDA | 2018-03-15 |
| Date Reported to Mfgr | 2018-03-15 |
| Date Added to Maude | 2018-03-30 |
| 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 | GLIDESCOPE GLIDERITE |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2018-03-30 |
| Catalog Number | 0270-0916 |
| Lot Number | GS43228 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERATHON INCORPORATED |
| Manufacturer Address | 20001 NORTH CREEK PARKWAY BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-30 |