MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-10 for JAUNDICE METER JM105 N/A manufactured by Draeger Medical Systems, Inc..
[107899071]
There is no indication that the meter did not function as intended. The users in this case misinterpreted the displayed "-o-" display for an out of range bilirubin reading. As a result there was a delay in treatment for the patient. An mri has revealed that there are 2 small brain lesions, which may be possibly attributed to jaundice. Draeger has initiated a field action.
Patient Sequence No: 1, Text Type: N, H10
[107899072]
Due to the unclear display, an increased bilirubin value was not detected. The treatment of the patient was therefore not initiated on time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2510954-2018-00004 |
| MDR Report Key | 7503544 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-10 |
| Date of Report | 2018-05-10 |
| Date of Event | 2017-12-17 |
| Date Mfgr Received | 2018-04-11 |
| Date Added to Maude | 2018-05-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. DHAVAL TRIVEDI |
| Manufacturer Street | 3135 QUARRY ROAD |
| Manufacturer City | TELFORD PA 18969 |
| Manufacturer Country | US |
| Manufacturer Postal | 18969 |
| Manufacturer Phone | 9783798077 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1220063-04/17/2018-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAUNDICE METER |
| Generic Name | NON-INVASIVE TRANSCUTANEOUS BILIRUBMINOMETER |
| Product Code | MQM |
| Date Received | 2018-05-10 |
| Model Number | JM105 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Device Expiration Date | 2000-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAEGER MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 3135 QUARRY ROAD TELFORD PA 18969 US 18969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-05-10 |