MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-06-06 for KONICA MINOLTA AIR-SHIELDS JAUNDICE METER JM-103 * manufactured by Draeger Medical, Inc..
[486603]
Nurse took a reading with the jaundice meter and got a reading of 7. 6. Serum that was drawn and sent at the same time was 12. 7, with a difference of 5. 1 points on baby's bilirubin level. All four jaundice meters were pulled because the department wasn't sure which unit had been used. Calibration on all four meters was done. They all calibrated out ok. All four units are being sent back to the manufacturer for testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 726097 |
| MDR Report Key | 726097 |
| Date Received | 2006-06-06 |
| Date of Report | 2006-06-06 |
| Date of Event | 2006-05-30 |
| Report Date | 2006-06-06 |
| Date Reported to FDA | 2006-06-06 |
| Date Added to Maude | 2006-06-16 |
| 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 | 0 |
| 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 | KONICA MINOLTA AIR-SHIELDS JAUNDICE METER |
| Generic Name | JAUNDICE METER |
| Product Code | LMX |
| Date Received | 2006-06-06 |
| Returned To Mfg | 2006-06-06 |
| Model Number | JM-103 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | R |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 714345 |
| Manufacturer | DRAEGER MEDICAL, INC. |
| Manufacturer Address | 3135 QUARRY ROAD TELFORD PA 18969 US |
| Brand Name | KONICA MINOLTA AIR-SHIELDS JAUNDICE METER |
| Generic Name | JAUNDICE METER |
| Product Code | LMX |
| Date Received | 2006-06-06 |
| Returned To Mfg | 2006-06-06 |
| Model Number | JM-103 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 2 |
| Device Event Key | 714346 |
| Manufacturer | DRAEGER MEDICAL, INC. |
| Manufacturer Address | 3135 QUARRY ROAD TELFORD PA 18969 US |
| Brand Name | KONICA MINOLTA AIR-SHIELDS JAUNDICE METER |
| Generic Name | JAUNDICE METER |
| Product Code | LMX |
| Date Received | 2006-06-06 |
| Returned To Mfg | 2006-06-06 |
| Model Number | JM-103 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 3 |
| Device Event Key | 714347 |
| Manufacturer | DRAEGER MEDICAL, INC. |
| Manufacturer Address | 3135 QUARRY ROAD TELFORD PA 18969 US |
| Brand Name | KONICA MINOLTA AIR-SHIELDS JAUNDICE METER |
| Generic Name | JAUNDICE METER |
| Product Code | LMX |
| Date Received | 2006-06-06 |
| Returned To Mfg | 2006-06-06 |
| Model Number | JM-103 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 4 |
| Device Event Key | 714348 |
| Manufacturer | DRAEGER MEDICAL, INC. |
| Manufacturer Address | 3135 QUARRY ROAD TELFORD PA 18969 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-06 |