MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-10-13 for CUFF, TRACHEAL TUBE, INFLATABLE manufactured by Unknown.
[89296728]
Patient Sequence No: 1, Text Type: N, H10
[89296729]
Medtronic received a communication regarding a cuff inflation/deflation issue. According to the reporter, the internal balloon did not deflate when the air was sucked into the syringe but it did inflate when air was blown in by the syringe. The customer indicated that extubation and re-intubation in emergency were required. No further injury was reported and the patient recovered. The customer was not able to provide the lot or reference numbers which determine the manufacturer, date of manufacture, and 510k number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2017-05561 |
| MDR Report Key | 6949199 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-13 |
| Date of Report | 2017-06-28 |
| Date Mfgr Received | 2017-06-28 |
| Date Added to Maude | 2017-10-13 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | UNKNOWN |
| Manufacturer City | UNKNOWN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CUFF, TRACHEAL TUBE, INFLATABLE |
| Product Code | BSK |
| Date Received | 2017-10-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-13 |