MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-24 for MCO-5M manufactured by Sanyo/panasonic.
[39311435]
In-vitro fertilization clinic thirteen embryos belonging to one patient experienced significant developmental delay and possible cellular arrest due to an incubator malfunction. There was no physical harm to the patient involved. This is not a device or product, it's a piece of equipment. This event involves an incubator. A failure of the led rh pan light on display sensor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060561 |
| MDR Report Key | 5466414 |
| Date Received | 2016-02-24 |
| Date of Report | 2016-02-24 |
| Date of Event | 2016-01-24 |
| Date Added to Maude | 2016-02-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MCO-5M |
| Generic Name | MCO-5M |
| Product Code | MQG |
| Date Received | 2016-02-24 |
| ID Number | 11040057 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SANYO/PANASONIC |
| Manufacturer Address | WOOD DALE CA 60191 US 60191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-02-24 |