MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-29 for VITAL SIGNS BROSELOW PEDIACTRIC EMERGENCY SYSTEM KIT AE4700 * manufactured by Ge Healthcare (vital Signs).
[18844963]
Possible contained potential contaminated providine iodine swabs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2532358 |
| MDR Report Key | 2532358 |
| Date Received | 2012-03-29 |
| Date of Report | 2012-03-29 |
| Date of Event | 2011-10-17 |
| Report Date | 2012-03-29 |
| Date Reported to FDA | 2012-03-29 |
| Date Added to Maude | 2012-04-12 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | VITAL SIGNS BROSELOW PEDIACTRIC EMERGENCY SYSTEM KIT |
| Generic Name | PEDIATRIC EMERGENCY SYSTEM KIT |
| Product Code | OKI |
| Date Received | 2012-03-29 |
| Returned To Mfg | 2011-10-24 |
| Model Number | AE4700 |
| Catalog Number | * |
| Lot Number | 0810822 |
| ID Number | * |
| Device Availability | R |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE (VITAL SIGNS) |
| Manufacturer Address | 20 CAMPUS RD. TOTOWA NJ 07512 US 07512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-29 |