MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-08-25 for STAN S31 FETAL HEART MONITOR SBS 101 003 manufactured by Neoventa Medical Ab.
[1381577]
The stan unit started to smell like burning plastic. A nurse trying to turn the unit off touched the main switch, and it was so hot she instantly pulled her finger away. There was no remaining or residual mark, etc. Noted by the midwife on her finger.
Patient Sequence No: 1, Text Type: D, B5
[8751097]
Although the initial reportability decision indicated that this was not a reportable event in the us, in response to the fda warning letter of august 4, 2010, and capa project (b)(4), this event will be reported in the us. We are aware that reporting timelines cannot be met with the retrospective reporting.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004729605-2010-00008 |
| MDR Report Key | 1819977 |
| Report Source | 08 |
| Date Received | 2010-08-25 |
| Date of Report | 2010-08-19 |
| Date of Event | 2009-03-09 |
| Date Mfgr Received | 2009-03-09 |
| Date Added to Maude | 2012-03-12 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA GRANBERG, MEDICAL DIR |
| Manufacturer Street | AGATAN 32 |
| Manufacturer City | MOLNDAL SE-431 35 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-431 35 |
| Manufacturer Phone | 17583200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAN S31 FETAL HEART MONITOR |
| Generic Name | HEO: OBSTETRIC DATA ANALYZER |
| Product Code | HEO |
| Date Received | 2010-08-25 |
| Returned To Mfg | 2009-04-09 |
| Model Number | STAN S31 |
| Catalog Number | SBS 101 003 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOVENTA MEDICAL AB |
| Manufacturer Address | MOLNDAL SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-08-25 |