MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-12 for RC1000 RC1000BED manufactured by Camtec.
[141772882]
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Patient Sequence No: 1, Text Type: N, H10
[141772883]
It was reported to the manufacturer by the end user, per the end user, "patient fell between side rails and hit her head". Numerous requests to this facility have been made to receive additional information and details related to this alleged incident report with no response from the facility. Complaint# (b)(4) and ra# (b)(4) were entered into our system to have the bed returned to joerns for investigation. As of this writing, the bed have not been returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009402404-2019-00021 |
| MDR Report Key | 8509506 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-03-22 |
| Date Mfgr Received | 2019-03-25 |
| Date Added to Maude | 2019-04-12 |
| 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 | FELICIA BANKS |
| Manufacturer Street | 2100 DESIGN ROAD |
| Manufacturer City | ALINGTON TX 76014 |
| Manufacturer Country | US |
| Manufacturer Postal | 76014 |
| Manufacturer Phone | 8008260270 |
| Manufacturer G1 | CAMTEC |
| Manufacturer Street | 1959 CHURCH CREEK RD |
| Manufacturer City | CAMBRIDGE MD 21613 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21613 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RC1000 |
| Generic Name | BARIATRIC PATIENT BED |
| Product Code | OSI |
| Date Received | 2019-04-12 |
| Model Number | RC1000BED |
| Catalog Number | RC1000BED |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAMTEC |
| Manufacturer Address | 1959 CHURCH CREEK RD CAMBRIDGE MD 21613 US 21613 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-12 |