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 CUFFLATOR ENDO TUBE INFLATOR & MANOMETER 8199 manufactured by J. T. Posey Co..
[3110901]
The customer reported the needle will not rest at zero on the cufflator during set-up. The customer did not specify the date when this was discovered. There was no patient incident or injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10350469]
Eval results: eval of the returned product confirmed the reported issue. The needle does not rest at zero. When pressure is attempted the needle moves up abruptly but comes back down on its own. The needle stops at 98 on the dial plate. The rubber protective ring is missing on the cufflator. Note: the instructions for use state: the cufflator should be calibrated annually, or if measurements all outside of a specific 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 cufflator body. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020362-2012-00661 |
| MDR Report Key | 2903082 |
| Report Source | 05,06 |
| Date Received | 2012-11-30 |
| Date of Report | 2012-11-12 |
| Date Mfgr Received | 2012-11-12 |
| 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 | 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 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 ENDO TUBE INFLATOR & MANOMETER |
| Product Code | BSK |
| Date Received | 2012-11-30 |
| Returned To Mfg | 2012-11-19 |
| Model Number | 8199 |
| Catalog Number | 8199 |
| Lot Number | 1213741 |
| 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 |