MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-18 for NARA, DOMESTIC 4402000001 manufactured by Stryker Medical-kalamazoo.
[114685611]
It was reported the bassinet tub/basket could not lock into place, indicating a potential of the basket falling off. There was no reported patient involvement, medical intervention, or clinically significant delay in treatment as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
[131588013]
It was clarified that there was no malfunction with this device.
Patient Sequence No: 1, Text Type: N, H10
[131588014]
It was reported the bassinet tub/basket could not lock into place, indicating a potential of the basket falling off. There was no reported patient involvement, medical intervention, or clinically significant delay in treatment as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-00770 |
| MDR Report Key | 7699810 |
| Date Received | 2018-07-18 |
| Date of Report | 2018-12-12 |
| Date of Event | 2018-06-21 |
| Date Mfgr Received | 2018-06-21 |
| Date Added to Maude | 2018-07-18 |
| 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. KRISTEN CANTER |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693292100 |
| Manufacturer G1 | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NARA, DOMESTIC |
| Generic Name | BASSINET, HOSPITAL |
| Product Code | NZG |
| Date Received | 2018-07-18 |
| Catalog Number | 4402000001 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Address | 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-18 |