MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-28 for NELLCOR 10005941J manufactured by Mediana Co. Ltd..
[181384455]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[181384456]
According to the reporter, the patient was using the device at home and died. Additional information on the cause of death and details surrounding the event could not be provided. There is no alleged failure of the device and no information to suggest the device is related to the patient death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00173 |
| MDR Report Key | 9770003 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2019-07-15 |
| Date Mfgr Received | 2019-07-17 |
| Date Added to Maude | 2020-02-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | AVI KLUGER |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | MEDIANA CO. LTD. |
| Manufacturer Street | 1650 1 2 DONGHWA RI MUNMAK EU |
| Manufacturer City | KANGWON DO WONJU SI 00000 |
| Manufacturer Country | KR |
| Manufacturer Postal Code | 00000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NELLCOR |
| Generic Name | OXIMETER |
| Product Code | DQA |
| Date Received | 2020-02-28 |
| Model Number | 10005941J |
| Catalog Number | 10005941J |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIANA CO. LTD. |
| Manufacturer Address | 1650 1 2 DONGHWA RI MUNMAK EU KANGWON DO WONJU SI 00000 KR 00000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-28 |