Med-Mizer, a maker of electric, adjustable and bariatric hospital beds, received an FDA warning letter for failing to submit a timely MDR following a patient death.

The patient was in the “low position” in a bed and tried to exit, but their head wound up between the mattress and the side rail, leading to their death, according to the July 21 letter posted online. The company did not file an MDR. During the inspection, the Batesville, Ind., company said it did not have an MDR procedure for the AC-Powered Adjustable Hospital Bed.

Another observation related to a 2008 field correction for weld issues with Model SS hospital beds. The company replaced 25 beds at the time and repaired about 124 beds total, but did not submit a written report to the FDA, the warning letter says.

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