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..
[182770650]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182770651]
According to the reporter, during use, the device had false/unreliable reading of the spo2 and the pleth. They replaced the sensor with a new cable, but the issue was remaining inadequate reading. It was never clear when exactly the false value did appear. It was on several different children with different conditions. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00197 |
| MDR Report Key | 9810851 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2014-03-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 220-801 |
| Manufacturer Country | KR |
| Manufacturer Postal Code | 220-801 |
| 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 |
| Returned To Mfg | 2020-03-06 |
| Model Number | 10005941 |
| Catalog Number | 10005941 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 220-801 KR 220-801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |