MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-02-20 for CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER 8199 manufactured by J. T. Posey Co..
[19200008]
The customer reported the cufflator has an unstable pointer that will not go to zero on the dial. The customer did not provide the date when this was discovered. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[19475863]
Results: evaluation of the returned product confirmed the reported issue the needle does not return to zero when inflated, it will only return to 60 mmhg. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020362-2013-00087 |
| MDR Report Key | 3012593 |
| Report Source | 06 |
| Date Received | 2013-02-20 |
| Date of Report | 2013-02-01 |
| Date Mfgr Received | 2013-02-01 |
| Date Added to Maude | 2013-05-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAM WAMPLER, ADMINISTRATOR |
| 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 | 3 |
| Brand Name | CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER |
| Product Code | BSK |
| Date Received | 2013-02-20 |
| Returned To Mfg | 2013-02-07 |
| Model Number | 8199 |
| Catalog Number | 8199 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-02-20 |