MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-01-31 for ENDOTRACHEAL TUBE INFLATOR AND MANOMETER 8199 manufactured by J. T. Posey Co..
[3174766]
Customer reported the faceplate is missing and the needle is broken. The customer did not provide a date when this was discovered. No pt incident or injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[10522464]
Results: evaluation of the returned unit did not confirm the reported issue. Instead found that the faceplate is chipped but not missing. The needle moves up and the cufflator holds pressure as it should. Needle does not reset to zero, instead needle only resets to 116. Initially, needle reading was at zero. No readings can be taken since needle does not reset to zero. Note: instructions for use state: 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 | 2020362-2013-00041 |
| MDR Report Key | 2982843 |
| Report Source | 06 |
| Date Received | 2013-01-31 |
| Date of Report | 2013-01-11 |
| Date Mfgr Received | 2013-01-23 |
| Date Added to Maude | 2013-04-17 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOTRACHEAL TUBE INFLATOR AND MANOMETER |
| Product Code | BSK |
| Date Received | 2013-01-31 |
| Returned To Mfg | 2013-01-16 |
| Model Number | 8199 |
| Catalog Number | 8199 |
| Lot Number | NA |
| 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 | 2013-01-31 |