MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-20 for CUFFLATOR ENDOTRACHEAL TUBE INFLATOR AND MANOMETER (POCKET SIZE) 8199P manufactured by J. T. Posey Co..
[3197619]
The customer reported the cufflator will not hold pressure. The customer did not provide a date when this was discovered. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10630488]
The product was requested to be returned but has not been received. Note: this model of cufflator is 3 years old. Note: the information in this report is based solely on the customers initial report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020362-2013-00086 |
| MDR Report Key | 3012591 |
| Report Source | 05,06 |
| Date Received | 2013-02-20 |
| Date of Report | 2013-01-24 |
| Date Mfgr Received | 2013-01-24 |
| Date Added to Maude | 2013-05-01 |
| 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 (POCKET SIZE) |
| Product Code | BSK |
| Date Received | 2013-02-20 |
| Model Number | 8199P |
| Catalog Number | 8199P |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2013-02-20 |