MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-11-26 for MANOSCAN RFG-3890 manufactured by Given Imaging Los Angeles Llc.
[128246563]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[128246564]
According to the reporter, when they attempted to extubate the patient, but the probe was stuck, and they had a difficulty removing it. They had to contact the ears, nose, throat (ent) department which took 2 hours. The catheter was in the patient's cricothyroid and they had to use a scope to check the location and remove it. The patient experience bleeding in the nasal cavity, but they were able to stop the bleeding and the patient was stable. They will not repeat the study. Technical support connected to the system and completed a search for the file but was still unable to find the study.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005344223-2018-00012 |
| MDR Report Key | 8100693 |
| Report Source | USER FACILITY |
| Date Received | 2018-11-26 |
| Date of Report | 2018-11-26 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-11-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | GIVEN IMAGING LOS ANGELES LLC |
| Manufacturer Street | 5860 UPLANDER WAY |
| Manufacturer City | CULVER CITY CA 90230 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90230 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANOSCAN |
| Generic Name | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) |
| Product Code | FFX |
| Date Received | 2018-11-26 |
| Model Number | RFG-3890 |
| Catalog Number | RFG-3890 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LOS ANGELES LLC |
| Manufacturer Address | 5860 UPLANDER WAY CULVER CITY CA 90230 US 90230 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-26 |