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..
[3110902]
The customer reported the cufflator does not hold pressure during set-up. The customer did not provide the date when this was discovered. There was no patient incident or injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10350470]
Results? Eval of the returned product confirmed the reported issue. When pressure is attempted on the cufflator the needle moves up but comes down slowly on its own. The needle sits -2cm below zero on the dial. No physical damages to the unit found. 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 | 2020362-2012-00662 |
| MDR Report Key | 2903084 |
| 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 | 02152319 |
| 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 |