MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-07 for OLYMPIC 56320 manufactured by Olympic Now Known As Natus Medical.
[82370042]
Olympic neonatal scale plugged into outlet and plug blew and nurse received mild shock. Investigation of equipment by bio-med engineering revealed the cord cap on the scale was damaged. The cord cap was replaced and the scale was checked and returned to service. Hospital electrician also checked all the outlets in the room and they were found to be in good working order.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071443 |
| MDR Report Key | 6776677 |
| Date Received | 2017-08-07 |
| Date of Report | 2017-08-07 |
| Date of Event | 2017-07-24 |
| Date Added to Maude | 2017-08-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | OLYMPIC |
| Generic Name | NEONATAL SCALE |
| Product Code | FRW |
| Date Received | 2017-08-07 |
| Model Number | 56320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | OLYMPIC NOW KNOWN AS NATUS MEDICAL |
| Brand Name | OLYMPIC |
| Generic Name | NEONATAL SCALE |
| Product Code | FRW |
| Date Received | 2017-08-07 |
| Model Number | 56320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS NOW KNOWN AS NATUS MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-07 |