MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-04 for NELLCOR manufactured by Tyco Healthcare Group Lf - Nellcor Puritan Bennett Div..
[3534937]
Pedi-caps didn't turn color when trying to identify if pt still intubated. Third one used on pt did not turn color indicating pt was still intubated when endotracheal tube still in exact same position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030442 |
| MDR Report Key | 3151774 |
| Date Received | 2013-06-04 |
| Date of Report | 2013-05-24 |
| Date of Event | 2013-02-14 |
| Date Added to Maude | 2013-06-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NELLCOR |
| Generic Name | PEDI-CAP CO2 DETECTOR, #1 |
| Product Code | CCL |
| Date Received | 2013-06-04 |
| Lot Number | 0238052 |
| ID Number | (01)00840029001493 |
| Device Expiration Date | 2013-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TYCO HEALTHCARE GROUP LF - NELLCOR PURITAN BENNETT DIV. |
| Manufacturer Address | PLEASANTON CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-04 |