MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2013-02-14 for INFLATABLE TRACHEAL TUBE, CUFF 8199 manufactured by J. T. Posey Co..
[58535148]
Eval of the returned product did not confirm the reported issue that the unit intermittently holds pressure and readings are not accurate. The unit holds pressure continuously as it should and no intermittency was observed. However, the needle does not return to zero, instead it returns to its initial position in between 0 and 120, as a result no reading could be taken. The unit rubber protective ring is missing. Mfr ref file # 2013-06477.
Patient Sequence No: 1, Text Type: N, H10
[58535149]
Customer reported that cufflator intermittently holds pressure and when it does, the readings are not accurate. There was no pt incident or injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020362-2013-00060 |
| MDR Report Key | 3004916 |
| Report Source | DISTRIBUTOR |
| Date Received | 2013-02-14 |
| Date of Report | 2013-01-18 |
| Date Mfgr Received | 2013-01-18 |
| Date Added to Maude | 2013-03-14 |
| 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 | MARY SEGURA |
| Manufacturer Street | 5635 PECK RD. |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Manufacturer G1 | J. T. POSEY CO. |
| Manufacturer Street | 5635 PECK RD. |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INFLATABLE TRACHEAL TUBE, CUFF |
| Product Code | BSK |
| Date Received | 2013-02-14 |
| Returned To Mfg | 2013-02-06 |
| Model Number | 8199 |
| Catalog Number | 8199 |
| Lot Number | 07053355 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J. T. POSEY CO. |
| Manufacturer Address | ARCADIA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-14 |