MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-12-05 for INFANT NASAL CPAP CANNULA 1691 manufactured by Teleflex Medical.
[767096]
User facility has reported, that the pressure port on the cannula was occluded, resulting in high pressure alarms on ventilator. No adverse outcome to the infant.
Patient Sequence No: 1, Text Type: D, B5
[8015281]
During a previous investigation, product was found to have the reported condition. Teleflex medical is adding the following statement to the device ifu: warning: verify detection of a pressure reading prior to pt use. An airway/cpap pressure reading should be detectable on the ventilator or external pressure monitor. Customers who have purchased this product are being notified, via a recall notification, of the new warning statement. A copy of the customer notification is enclosed for your review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2007-00055 |
| MDR Report Key | 958707 |
| Report Source | 06 |
| Date Received | 2007-12-05 |
| Date of Report | 2007-01-30 |
| Date of Event | 2006-11-16 |
| Date Mfgr Received | 2007-01-30 |
| Date Added to Maude | 2008-03-18 |
| 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 | TED MARTINEZ, INTERIM MGR |
| Manufacturer Street | 4024 STIRRUP CREEK DR. STE. 710 |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9194334956 |
| Manufacturer Street | AVE. TRANSFORMACION #512 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFANT NASAL CPAP CANNULA |
| Generic Name | CPAP CANNULA |
| Product Code | NHJ |
| Date Received | 2007-12-05 |
| Model Number | NA |
| Catalog Number | 1691 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 956200 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO, TAMAULIPAS MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-05 |