[4716766]
On (b)(6) 2014, a clinical consultant (rn, bsn) for honeywell hommed received info concerning a pt with a defibrillator who had received a shock while standing on a wireless scale. Honeywell hommed's home telehealth monitoring system was installed in the pt's home on (b)(6) 2014. The monitoring system consisted of the following: genesis touch monitor (honeywell hommed medical device application loaded unto a (b)(6) tablet (b)(4) ); wireless blue tooth scale; wireless blue tooth oximeter choicemmed (b)(6) ; wireless blue tooth blood pressure monitor and (b)(4) and hommed (juno) wireless blue tooth scale. The installer performed a full set of vitals on the pt at the time of installation without incident. A few days later, during an unrelated hospital visit, the pt informed the nurse of the incident. The nurse indicated she could use the monitor (tablet) as long as it was 6 inches from her body but should not stand on the scale as it would cause the defibrillator to shock. The pt did not receive any additional medical attention and functions normally at home. This pt is no longer being monitored using honeywell hommed telehealth monitoring system. The customer did not indicate that there was nay scale damage. The honeywell hommed (juno) wireless scale is battery or ac operated. The scale has a capacity of 500 lbs (227kg) and collects weight using four load cells, one in each corner of the scale. The scale has a textured polycarbonate top and the polycarbonate bottom is supported with four rubber feet. The blue tooth radio contained within the scale has a maxium range of 10 meters or 33 feet. The scale does not have a user interface to visibly read a weight result and must be used with the genesis touch monitor to visibly review the weight result. This scale is not a electronic body fat scale. Product labeling was evaluated and found to be adequate for the genesis touch user manual (p4820en) which indicates the manual warnings: implantable medical devices. When the unit is turned on, a minimum separation of six (6) inches should be maintained between the monitor and an implantable medical device, such as a pacemaker or implantable cardioverter-defibrillator, to avoid potential interference with the unit. Turn off the unit if there is any reason to suspect interference. However, this specific warning was not found in the pt telemonitoring instructions (p4815en). This manual will be updated to reflect the same warnings and cautions found in the genesis touch user manual (p4820en). A review of the honeywell hommed complaint database found no other related complaints for the scale or monitor product. On 08/01/2014, honeywell database found no other related complaints for the scale or monitor product. On 08/01/2014, honeywell hommed requested all of the devices used for this pts monitoring to be returned for examination.
Patient Sequence No: 1, Text Type: D, B5