Serial number: (b)(4).For the two reported events, ge healthcare (gehc) reported a field modification for this issue per 21 cfr 806 on 20 march 2019.The gehc internal field modification number is (b)(4).Customers were sent a letter explaining the issue and requesting the customer to inspect the warmer bedside panel latch areas.Replacement of broken bedside panels will be provided by gehc.A set of warning labels will be supplied for application to the bedside panels.These labels will warn the user to not use the bedside panels for maneuvering the warmer and indicate the correct method of maneuvering the warmer.An addendum to the operation and maintenance manual will also be provided emphasizing the need to check and ensure that the bedside panels and latches are not cracked, broken, or damaged before every patient use.The addendum will also contain instructions to increase detectability of broken or cracked bedside panels.
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This report summarizes 2 malfunction event.A review of the events indicated that model m1112198 infant radiant warmer had a problem with the protective measure.1 was reported the front glass panel at the foot end will not stay up which could cause a patient fall, and 1 was reported for front panel not latching correctly which could cause a patient fall these reports were received from various sources.Of the 2 events, 2 did not involve patients.
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