MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-12 for PORTEX? PRESSUREEASY? CUFF PRESSURE MONITOR manufactured by Smiths Medical, Asd, Inc..
[105521725]
Patient Sequence No: 1, Text Type: N, H10
[105521726]
It was reported that a portex? Pressureeasy? Cuff pressure monitor failed to accurately monitor tracheal cuff pressure. The device required inflation because the green line was not visible. The patient had increased respiratory rate and was not synchronizing with the ventilator. The patient had a gurgling sound on expiration. Oral suction was given and patient continued to make a gurgling noise. The device was disconnected and rechecked with a manometer, showing a presure of 0. The use of the device was discontinued and the staff returned to four hourly cuff pressure checks. Does not appear patient was harmed in this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-01108 |
| MDR Report Key | 7426406 |
| Date Received | 2018-04-12 |
| Date of Report | 2018-04-12 |
| Date of Event | 2017-09-09 |
| Date Mfgr Received | 2018-03-19 |
| Date Added to Maude | 2018-04-12 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | DUBLIN SHARED SERVICES CENTER |
| Manufacturer Street | 5200 UPPER METRO PLACE SUITE 200 |
| Manufacturer City | DUBLIN OH 43017 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 43017 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PORTEX? PRESSUREEASY? CUFF PRESSURE MONITOR |
| Generic Name | CUFF, TRACHEAL TUBE, INFLATABLE |
| Product Code | BSK |
| Date Received | 2018-04-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL, ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-12 |