MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-16 for POSEY CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER 8199 manufactured by J. T. Posey Co..
[3031357]
The customer reported the cufflator needs calibration. The customer did not specify when this was discovered. There was no physical or functional issues reported. There was no patient incident or injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10299297]
Evaluation of the returned product found the needle on the dial plate is sitting between the 0 and the 2 cm h20. No readings taken due to the needle position. There was no physical damage found to the unit. Note: instructions for use has a warning statement: the cufflator should be calibrated annually, or if measurements fall outside of a suggested range, or if the cufflator needle does not indicate a reading of zero when nothing is connected, or if the unit is ever dropped. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020362-2012-00598 |
| MDR Report Key | 2826143 |
| Report Source | 05,06 |
| Date Received | 2012-10-16 |
| Date of Report | 2012-09-04 |
| Date Mfgr Received | 2012-10-02 |
| Date Added to Maude | 2013-01-29 |
| 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 | 6264433148 |
| 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 | POSEY CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER |
| Product Code | BSK |
| Date Received | 2012-10-16 |
| Model Number | 8199 |
| Catalog Number | 8199 |
| Lot Number | 07013849 |
| 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 | 2012-10-16 |