MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-10 for NELLCOR 10005941 manufactured by Mediana Co. Ltd..
[182770958]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182770959]
According to the reporter, the unit had low spo2 reading. It was indicated that desaturation and tachycardia record for spo2 readings was 76% and heart rate of 239 but newborn did not manifest any signs of distress. Follow up report stated that there was no death or any patient injury accompanied with customer complaint on the fluctuation of reading and the first feedback was not accurate and was related to another event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00198 |
| MDR Report Key | 9811865 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-10 |
| 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 | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| 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 | 2020-03-10 |
| Model Number | 10005941 |
| Catalog Number | 10005941 |
| 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 | 2020-03-10 |