On 12/17/2014, carefusion became aware that there was a second similar event involving another patient.Carefusion will submit a separate medwatch for that event.The user facility did not submit a user facility report to the mfr.(b)(4).The following info concerning the evaluation of the device is a summary of the info documented by the carefusion field service rep.The carefusion field service rep evaluated the device and in consultation with a carefusion technical support rep determined that the most likely cause of the reported event was an issue with the model: tmx425c treadmill, sn: (b)(4) manufactured by (b)(4).The carefusion field service rep advised the user facility to contact (b)(4) and have them come in and evaluate the treadmill.Carefusion contacted (b)(4) and they confirmed that the tmx425c treadmill, sn: (b)(4) was manufactured on 12/31/2001.They further stated that this product is no longer manufactured by them though it is still being services by them and is not yet obsolete.The (b)(4) rep indicated that an intermittent interface cable can cause speed changes and recommended that the user facility have the treadmill calibrated.For customer satisfaction, carefusion has shipped the user facility a new treadmill and recommended that they take the old treadmill out of service.
|