Recall Z-2554-2014 ยท KMI Monitor, Bed Patient
Curbell Medical, Inc.
CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed Patient Monitor --- Monitor is connected to a sensor pad that monitors the patient if they attempt to arise from a bed, chair, floor mat, or toilet seat. The monitor will sound an alarm.
| Date | Aug 26, 2014 (initiated Aug 5, 2014) |
| Status | Terminated |
| Reason | The firm became aware of a potential problem that was initiated by a customer complaint. After consultation with the manufacturer, it was discovered that a resistor was incorrectly placed within the circuit board on the monitor. This change to the resistor was a planned change to address a product improvement (improve battery drain). However, this modification rendered the monitor's alarm via the nurse call communication port to not function. |
| Root cause | Component design/selection |
| Action | Urgent Medical Device Recall Letters (dated 8/01/14) and Response Forms were sent to the consignees via e-mail (w/read receipt) on 8/05/14. |
| Quantity | Domestic: 112 units; Foreign: 211 units |
| Distribution | Nationwide, Canada, Ireland, Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.