MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-11 for UNKNOWN MICROCUFF ENDOTRACHEAL TUBE manufactured by Avanos Medical Inc..
[182908224]
The actual complaint product was not returned for evaluation. Root cause could not be determined. A review of the device history record is in-progress. All information reasonably known as of 10 mar 2020 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. Avanos medical inc. Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the avanos medical inc. Complaint database and identified as complaint (b)(4). This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc. Product is defective or caused serious injury.
Patient Sequence No: 1, Text Type: N, H10
[182908225]
Fda medwatch / fda user facility report # mw 4200070000-2020-8001 received on (b)(6) 2020, and the following information was provided: "endotracheal tube cuff deflated without any warning, resulting in patient not getting sufficient tidal volumes. " the original intended procedure was "to use ett [endotracheal tube] for ventilation while on vent. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011270181-2020-00044 |
| MDR Report Key | 9817330 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-11 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | COMMAND MEDICAL NICARAGUA SA |
| Manufacturer Street | KM 12.5 CARRETERA NORTE PARQUE INDUSTRIAL LAS MERCEDES |
| Manufacturer City | MANAGUA, MANAGUA |
| Manufacturer Country | NU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN MICROCUFF ENDOTRACHEAL TUBE |
| Generic Name | VAP MICROCUFF ENDOTRACHEAL TUBES |
| Product Code | BTR |
| Date Received | 2020-03-11 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | CM8214002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVANOS MEDICAL INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |