MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-11-02 for CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER 8199 manufactured by J.t. Powey Company.
[2952168]
The customer reported the cufflator does not hold pressure. The customer did not specify what date the issue was discovered. There was no pt incident or injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10230417]
Results: evaluation of the returned product confirmed the reported issue, needle moves up but does not hold pressure. No readings can be taken since the cufflator does not hold pressure. Rubber protective ring has cuts going around its circumference. Note: the instructions for use states: the cufflator should be calibrated annually, or if measurements fall outside of a 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 | 2020362-2012-00638 |
| MDR Report Key | 2860228 |
| Report Source | 01,08 |
| Date Received | 2012-11-02 |
| Date of Report | 2012-10-15 |
| Date Mfgr Received | 2012-10-15 |
| Date Added to Maude | 2013-02-08 |
| 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 | 2012-11-02 |
| Returned To Mfg | 2012-10-26 |
| Model Number | 8199 |
| Catalog Number | 8199 |
| Lot Number | 08026457 |
| 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. POWEY COMPANY |
| Manufacturer Address | ARCADIA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-02 |