The following fields were updated due to additional information: d10: device available for eval yes,.D10: returned to manufacturer on: 2022-01-15.H6: investigation summary the complaint was created for unit won¿t turn on/off issues on the bd veritor plus analyzer (p/n 256066, s/n (b)(6)).The customer reports of analyzer catching fire.The device history record for bd veritor plus analyzer, sn (b)(6), was examined and showed no discrepancies related to this issue that can be correlated to this complaint.The reader passed all the tests including the final assembly process, oqa, source inspection, functionality, final packing test and manual inspection.The veritor plus analyzer, (b)(6) was received.The analyzer shows extensive heat damage.The internal and external damage to the plastic parts, main circuit board, and battery cell are consistent with thermal runaway of the li-ion cell.The plastic damage indicates that the internal temperature in the instrument was sufficiently high to melt the plastic components before the catastrophic failure occurred.The damage to the instrument is too extensive to identify the root cause.Two other analyzers were also returned sn (b)(6) component is damaged, instrument powers only with dc input, turns off immediately if dc input is removed.Sn (b)(6)-instrument charges battery normally, no excessive current.Instrument operates normally with or without dc input.Based on this evidence the complaint is confirmed.Bd quality will continue to monitor for trends related to the veritor system and power issues.H3 other text : see h10.
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