MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-07 for CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER 8199 manufactured by J. T. Posey Co..
[17955476]
The customer reported the cufflator is missing the front face plate and the dial needle. The customer reported the plate ring is corroded. The customer did not provide a date when the issue was discovered. There was no pt incident or injury reported.
Patient Sequence No: 1, Text Type: D, B5
[18051520]
Result - eval of the returned product confirmed the issue; the o-ring is corroded. Reported issue of missing needle and face plate is not confirmed. Needle moves up and holds pressure. Needle does not reset to zero, instead it returns to its initial position below zero. No readings taken since needle does not reset to zero. Note: the instructions for use has a statement: the cufflator should be calibrated annually, or if measurements fall outside of a specified range, or if the cufflator needle does not indicate a reading of zero when nothing is connected, or if the unit is ever dropped. For service/repair: never open the posey cufflator body. If the posey cufflator body is opened, any damages that result will not be covered under warranty. Return all cufflators to the posey company for repair. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020362-2013-00053 |
| MDR Report Key | 2986045 |
| Report Source | 05,06 |
| Date Received | 2013-02-07 |
| Date of Report | 2013-01-09 |
| Date Mfgr Received | 2013-01-31 |
| Date Added to Maude | 2013-04-22 |
| 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 | CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER |
| Product Code | BSK |
| Date Received | 2013-02-07 |
| Returned To Mfg | 2013-01-23 |
| Model Number | 8199 |
| Catalog Number | 8199 |
| Lot Number | 07014090 |
| 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 | 2013-02-07 |