MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-12 for LD304 MATERNITY BED 4701000000 manufactured by Stryker Medical-kalamazoo.
[123666302]
Upon evaluation by the stryker service technician, it was found the left crank weldment had broken. Replacement parts have been ordered, but the customer requested closure of the service report, indicating they will be holding the bed as is until completion of their investigation.
Patient Sequence No: 1, Text Type: N, H10
[123666303]
It was reported the bed tipped to the side when the patient? S mother had her arms draped over the bed siderails. Allegedly the bed? Broke? And tilted to the patient left side, and was caught by the nurse on duty who injured her lower back. As the bed returned to the upright position, it caused pain to the patient? S mother? S shoulder. It was further reported the patient? S mother had a prior shoulder injury. It was reported by the labor and delivery supervisor that the nurse and the mother were both examined in the er and had x-rays performed as a diagnostic measure. The nurse? S x-ray was negative, but she did miss a couple of shifts at work due to soreness. The supervisor also indicated she believed the nurse may have received medication for pain. The supervisor did not have any details on the severity or treatment of the patient? S mother? S reported injury. While no adverse events were reported relating to the patient and infant, they were kept 24 hours for observation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-01090 |
| MDR Report Key | 7962327 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-10-12 |
| Date of Report | 2018-10-12 |
| Date of Event | 2018-09-18 |
| Date Mfgr Received | 2018-09-18 |
| Device Manufacturer Date | 2008-04-29 |
| Date Added to Maude | 2018-10-12 |
| 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 | 3 |
| Brand Name | LD304 MATERNITY BED |
| Generic Name | TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) |
| Product Code | HDD |
| Date Received | 2018-10-12 |
| Catalog Number | 4701000000 |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2018-10-12 |