MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-10-16 for POSEY CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER 8199 manufactured by J. T. Posey Co..
[20984187]
Customer returned the cufflator for calibration only. There was no functional or physical damage reported. The customer did not state when they discovered this issue. There was no patient incident or injury reported.
Patient Sequence No: 1, Text Type: D, B5
[21161922]
Results: evaluation of the returned product found the needle position on the dial plate is between 0 and 120 cm h20. The rubber protective ring is missing and the face plate has a foggy film over it. No readings were taken due to the needle position. Note: the instructions for use state: the cufflator should be calibrated annually, or if measurements fall outside of a set range, or if the cufflator needle does not indicate a reading of zero when nothing is connected, or if the unit is ever dropped. Warning statement: never open the posey cufflator body. If the posey cufflator body is opened, any damages that result will not be covered under warranty. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020362-2012-00596 |
| MDR Report Key | 2826133 |
| Report Source | 06 |
| Date Received | 2012-10-16 |
| Date of Report | 2012-08-30 |
| 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 | 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 | POSEY CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER |
| Product Code | BSK |
| Date Received | 2012-10-16 |
| Model Number | 8199 |
| Catalog Number | 8199 |
| Lot Number | 01008894 |
| 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 | 2012-10-16 |