MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-10 for PHOTO-THERAPY 4000 2M21700-23 manufactured by Draeger Medical Systems, Inc..
[116781499]
Orders to start infant on triple photo therapy. Tested strength of draeger at setup using photometer, found to be below required levels for proper treatment. Draeger taken out of patient room and tagged to not use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7773003 |
| MDR Report Key | 7773003 |
| Date Received | 2018-08-10 |
| Date of Report | 2018-08-02 |
| Date of Event | 2018-07-28 |
| Report Date | 2018-08-02 |
| Date Reported to FDA | 2018-08-02 |
| Date Reported to Mfgr | 2018-08-10 |
| Date Added to Maude | 2018-08-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHOTO-THERAPY 4000 |
| Generic Name | UNIT, NEONATAL PHOTOTHERAPY |
| Product Code | LBI |
| Date Received | 2018-08-10 |
| Model Number | 2M21700-23 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAEGER MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 6 TECH DR ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-10 |