Mindray—T1 Transport Monitor/Module Battery Packs: May Overheat

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In an April 21, 2017, Medical Device Correction letter submitted by an ECRI Institute member hospital, Mindray states that it has received 2 reports (from outside the U.S.) of the above battery packs overheating and forming a small, melted cavity in the outer housing. Mindray also states that in both reported instances, the battery emitted smoke and was hot to the touch, and that in 1 of the reported instances a small flame was noted on the battery surface. Mindray further states that it has received no reports of patient or caregiver injury as a result of this problem. Mindray states that if the battery overheats and results in the above monitor/modules being taken out of service, a risk to the patient may result from potential delay associated with locating another monitor. The manufacturer has not confirmed the...