Recall Z-1407-2010 ยท KMI Monitor, Bed Patient
AliMed Corporation
Product is a pull cord type monitor, bed patient alarm used to detect patient/resident movement. An adjustable cord is attached to both the alarm and the patient. When the patient moves beyond the length of the cord the pin is pulled and the alarm activated.
| Date | Apr 16, 2010 (initiated Feb 12, 2010) |
| Status | Terminated |
| Reason | Alimed became aware of issue via internal receiving inspection activities on 1/20/09. Firm states that subsequent to this observation, Customer Dissatisfaction inquiry #100192 was generated on 1/22/10. A single unit was received back by AliMed and 0 n/2/1/20 from a rehabilitation center that indicated that it had received a unit and it did not function upon its initial use. Failure of the alarm |
| Root cause | Device Design |
| Action | Letter sent to customers stating that some units may have been subjected to excessive heat during the manufacturing process causing internal distortion to a key alarm component. The letter also request that the Health Care professional review records and notify all users to whom the product may have been issued and if any product has been issued outside of their facility, to forward this correspondence to them. Firm has enclosed a form for return of the product and issuance of a new product. For questions, please contact the firm using the information provided in the letter. |
| Quantity | 30 units |
| Distribution | All product was distributed domestically with the exception of one unit sold in Canada. AliMed sells and distributes this product to medical health professionals and distributors as well as directly to end users |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.