We have been informed of the following event: "problem description problem description caller: hologic employee (tm) name: (b)(6).Part ship date: (b)(6) 2022.Date of procedure: (b)(6) 2023.Date product support or hologic employee notified of issue reported: 5/4/2023.Issue reported: negative deficit.Troubleshooting performed: performed a manual count.Dr.Who performed the procedure: unknown.Patient status: no injury reported or pae.Replacement requested: yes.Is product returning for investigation: yes.Detailed description: thomas reports that during a procedure today, the deficit suddenly dropped and went down to -300 and continued to drop.A manual count was required to complete the case.Thomas also reports that similar issues have happened in other cases, however he does not know specific numbers.Thomas was present for the case today.".
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No patient harm was reported.The description of the event is very poor and the end user has not re-sponded to our requests.However, the device was sent in for evaluation and it was determined that the weighing cells were warped.Therefore, it is confirmed that the scale malfunctioned.Deficit testing per-formed by the technical service of the manufacturer resulted in a deficit being too high, but it has not been confirmed that the displayed deficit has negative values.
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