MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for LULLABY LED PHOTOTHERAPY 2089203-001 manufactured by Wipro Ge Healthcare Private Ltd..
[145638280]
Ge healthcare?? S investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed. No patient information available at time of mdr filing. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[145638281]
The hospital reported that the screw caps of the lower housing are falling out and one was found in a baby's mouth. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617277-2019-00002 |
| MDR Report Key | 8545794 |
| Date Received | 2019-04-24 |
| Date of Report | 2019-11-08 |
| Date of Event | 2019-03-26 |
| Date Mfgr Received | 2019-11-03 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2019-04-24 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOHN SZALINSKI |
| Manufacturer Street | 3000 N GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LULLABY LED PHOTOTHERAPY |
| Generic Name | UNIT, NEONATAL PHOTOTHERAPY |
| Product Code | LBI |
| Date Received | 2019-04-24 |
| Model Number | 2089203-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WIPRO GE HEALTHCARE PRIVATE LTD. |
| Manufacturer Address | 4, KADUGODI INDUSTRIAL AREA, BANGALORE 560067 IN 560067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-24 |