MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-03-07 for CUFF INFLATOR PRESSURE GAUGE WITH CONNECTING TUBES 100/568/000 manufactured by Smiths Medical Asd, Inc..
[138149353]
Manufacture date of device unable with the information provided.
Patient Sequence No: 1, Text Type: N, H10
[138149354]
Information was received that a temporary ventilation failure had occured during surgery on a patient. It was reported that a smiths medical portex cuff inflator was faulty, as it was not deflating. Ventilator had alarmed "apnoea" and although ventilator bellows were filling, it was delivering ineffective tidal volumes and no co2 recorded. Cuff manometer already in place recording 20cm h2o, but additional cuff inflation to 30cm h2o did not improve mechanical ventilation. A new manometer was attached to endotracheal tube cuff and recorded 10 cm h20, so cuff inflated to 30cm h2o and mechanical ventilation subsequently resumed. Patient was manually ventilated during the incident. Adequate ventilation, oxygenation and delivery of volatile anaesthesia in manual mode from the same anaesthetic machine, so no sequelae or detriment to the patient. It was reported that a separate ambu bag was available for ventilation should that have failed as well. No patient injury resulted from the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-01286 |
| MDR Report Key | 8401136 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-07 |
| Date of Report | 2019-06-26 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-05-30 |
| Date Added to Maude | 2019-03-07 |
| 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 | SMITHS MEDICAL, ASD INC. |
| Manufacturer Street | BOUNDARY ROAD |
| Manufacturer City | KENT, HYTHE |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUFF INFLATOR PRESSURE GAUGE WITH CONNECTING TUBES |
| Generic Name | MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) |
| Product Code | CAP |
| Date Received | 2019-03-07 |
| Catalog Number | 100/568/000 |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2019-03-07 |