MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-11-07 for ENDOTRACHEAL TUBE INFLATOR AND MONOMETER 8199 manufactured by J. T. Posey Co..
[2904955]
Customer reported that they returned the cufflator for repair and when the cufflator was returned, the clip on the back was broken off and missing. The cufflator was returned without the original case but in a cardboard box. The customer did not provide a date when this was discovered and no patient incident or injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[10335285]
Evaluation results: evaluation of the returned unit confirmed the reported issue that the back clip was broken, missing and the cufflator was in a cardboard box. The cufflator holds pressure but does not result to zero when pressure is released. However, this lot number product returned is not the same lot number product that the customer initially reported was repaired. Note: instructions for use state that the cufflator should be calibrated annually, or if measurements fall outside of this 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 | 2020362-2012-00642 |
| MDR Report Key | 2865314 |
| Report Source | 05,06 |
| Date Received | 2012-11-07 |
| Date of Report | 2012-10-22 |
| Date Mfgr Received | 2012-11-05 |
| Date Added to Maude | 2013-02-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROXANA KOUSSA |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOTRACHEAL TUBE INFLATOR AND MONOMETER |
| Product Code | BSK |
| Date Received | 2012-11-07 |
| Returned To Mfg | 2012-10-30 |
| Model Number | 8199 |
| Catalog Number | 8199 |
| Lot Number | 00100742 |
| 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 | 2012-11-07 |