MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-11-30 for ENDOTRACHEAL TUBE INFLATOR AND MONOMETER 8199 manufactured by J. T. Posey Co..
[3110903]
Customer reported that the face plate is frosted, the needle is missing and calibration is needed. The customer did not provide a date when this was reported. There was no patient incident or injury.
Patient Sequence No: 1, Text Type: D, B5
[10350471]
Eval results: - eval of the returned unit confirms the reported issue the perflex face plate has a foggy film over it. However, the needle is not missing and moves up and holds pressure but does not return to zero, instead needle returns to its initial position below zero. No readings taken since the needle does not return to zero. 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 | 2020362-2012-00667 |
| MDR Report Key | 2903087 |
| Report Source | 05,06 |
| Date Received | 2012-11-30 |
| Date of Report | 2012-11-05 |
| Date Mfgr Received | 2012-11-14 |
| Date Added to Maude | 2013-03-07 |
| 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 MONOMETER |
| Product Code | BSK |
| Date Received | 2012-11-30 |
| Returned To Mfg | 2012-11-13 |
| Model Number | 8199 |
| Catalog Number | 8199 |
| Lot Number | 04092435 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J. T. POSEY CO. |
| Manufacturer Address | 5635 PECK RD. ARCADIA CA 91006 US 91006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-30 |