MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-01-31 for CUFFLATOR ENDOTRACHEAL TUBE INFLATOR & MONOMETER 8199 manufactured by J. T. Posey Co..
[3174756]
Original report indicates that the request is for service only. The customer reported they want the unit calibrated. Upon receipt and evaluation of the product, it was discovered that the cufflator does not zero. The customer did not provide a date when this was discovered. There was no pt incident or injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10521701]
Results: evaluation of the returned unit found that the needle is below zero. Cufflator holds pressure but needle jumps abruptly to 80 when inflating. Needle does not return to zero, instead it returns to its initial position below zero. No readings can be taken since needle jumps abruptly. Note: instructions for use state: before use, the control inflator needs to be checked by closing the connecting piece with the finger, then inflating with inflation bulb to 120 cm h20; value must be constant for 2-3 seconds. If the pressure drops, the device needs repair by the distributor. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020362-2013-00035 |
| MDR Report Key | 2982833 |
| Report Source | 05,06 |
| Date Received | 2013-01-31 |
| Date of Report | 2012-12-27 |
| Date Mfgr Received | 2013-01-22 |
| Date Added to Maude | 2013-04-17 |
| 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 | ROXANA KOUSSA |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUFFLATOR ENDOTRACHEAL TUBE INFLATOR & MONOMETER |
| Product Code | BSK |
| Date Received | 2013-01-31 |
| Returned To Mfg | 2013-01-11 |
| Model Number | 8199 |
| Catalog Number | 8199 |
| Lot Number | NA |
| 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 CO. |
| Manufacturer Address | ARCADIA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-31 |