MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06,07 report with the FDA on 2011-04-28 for GOODKNIGHT 420 GK420E M-113902-FR manufactured by Nellcor Puritan Bennett.
[2138835]
Covidien received a report stating blower doesn't blow. During investigation it was found that the inlet baffle foam was deteriorating. No patient harm reported at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008361498-2011-00003 |
| MDR Report Key | 2160313 |
| Report Source | 00,01,06,07 |
| Date Received | 2011-04-28 |
| Date of Report | 2011-04-19 |
| Date of Event | 2011-03-17 |
| Date Mfgr Received | 2011-04-19 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2011-08-24 |
| 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 | LISA CARDENAS |
| Manufacturer Street | 2101 FARADAY AVENUE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7606035073 |
| Manufacturer G1 | TYCO HEALTHCARE |
| Manufacturer Street | 10 ALLEEE PELLETIER DOISY |
| Manufacturer City | VILLIERS LES NANCY CEDEX 54601 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 54601 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOODKNIGHT 420 |
| Generic Name | CPAP MACHINE |
| Product Code | NNI |
| Date Received | 2011-04-28 |
| Model Number | GK420E |
| Catalog Number | M-113902-FR |
| ID Number | RX201104-1574 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NELLCOR PURITAN BENNETT |
| Manufacturer Address | 10 ALLEEE PELLETIER DOI NANCY FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-28 |