MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-01 for LD304 MATERNITY BED 4701000000 manufactured by Stryker Medical-kalamazoo.
[107206196]
It was reported the support arm of the bed detached when the bolt backed out. When this happened, the bed unexpectedly listed to that side and the patient went towards that side as well. The patient did not fall out of the bed as the nursing staff was there and held the bed up until another bed could be brought in. No adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-00445 |
| MDR Report Key | 7476750 |
| Date Received | 2018-05-01 |
| Date of Report | 2018-05-01 |
| Date of Event | 2018-04-03 |
| Date Mfgr Received | 2018-04-03 |
| Device Manufacturer Date | 2013-06-21 |
| Date Added to Maude | 2018-05-01 |
| 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. MARY KLAVER |
| 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 | LD304 MATERNITY BED |
| Generic Name | TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) |
| Product Code | HDD |
| Date Received | 2018-05-01 |
| Catalog Number | 4701000000 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-01 |