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 |