MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-11-16 for POSEY CUFFLATOR ENDO TUBE INFLATOR & MANOMETER 8199 manufactured by J. T. Posey Company.
[18048486]
The customer reported that the unit the needle stuck at about 40 mmhg mark. The customer did not provide the date when this was discovered. There was no pt incident or injury reported.
Patient Sequence No: 1, Text Type: D, B5
[18051445]
Eval results: eval of the returned product did not confirm the reported issue. The needle on the dial plate is at 42 mmhg. The needle moves up and holds pressure but when the pressure is released the needle returned to 75 mmhg. The rubber protective ring is missing from the cufflator. 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. 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 cufflator to the posey company for repair. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020362-2012-00653 |
| MDR Report Key | 2894262 |
| Report Source | 05,06 |
| Date Received | 2012-11-16 |
| Date of Report | 2012-10-25 |
| Date Mfgr Received | 2012-11-06 |
| Date Added to Maude | 2013-02-25 |
| 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 |
| Manufacturer Street | 5635 PECK RD. |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Manufacturer G1 | J. T. POSEY COMPANY |
| 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 ENDO TUBE INFLATOR & MANOMETER |
| Product Code | BSK |
| Date Received | 2012-11-16 |
| Returned To Mfg | 2012-11-02 |
| Model Number | 8199 |
| Catalog Number | 8199 |
| Lot Number | 1014688 |
| 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 COMPANY |
| Manufacturer Address | ARCADIA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-16 |