MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-24 for NI(NEED THE EXACT MODEL NAME) manufactured by Ni.
[343860]
In novermber 2004, sony electronics inc. Became aware that a lawsuit had been filed in the superior court (but had not yet been served on the named defendants, including sony electronics) alleging the wrongful death of pt due, at least in part, to the failure of a sony monitor being used, apparently, to read blood gas or oxygen flow levels. No other info on the monitor or the possible cause or contribution of the monitor to the alleged death is available from the source and is likely not to be because the matter is in litigation. Without specific info regarding the model number of the alleged monitor and the exact nature of the alleged failure, it is not possible to investigate any potential deficiency in any sony monitor or to compare it to any other complaints that may have been received. Sony electronics inc. Will, however, follow up on this matter when more info is forthcoming, and will provide further reports as appropriate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246606-2004-00001 |
| MDR Report Key | 556805 |
| Date Received | 2004-11-24 |
| Date of Report | 2004-11-22 |
| Date of Event | 2002-11-08 |
| Date Facility Aware | 2004-11-15 |
| Report Date | 2004-11-23 |
| Date Reported to FDA | 2004-11-23 |
| Date Added to Maude | 2004-12-01 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NI |
| Generic Name | NI(NEED THE EXACT MODEL NAME) |
| Product Code | CCL |
| Date Received | 2004-11-24 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 546473 |
| Manufacturer | NI |
| Manufacturer Address | NI NI * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2004-11-24 |