Model Number ALIZEA DR 1600 |
Device Problems
Labelling, Instructions for Use or Training Problem (1318); Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/20/2022 |
Event Type
malfunction
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Event Description
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Reportedly, the labels were different between three pacemakers, as the product name is not always the same size.
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Manufacturer Narrative
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The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.
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Manufacturer Narrative
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Review of the device history records confirmed that the devices were packaged in accordance with all applicable procedures.The size of the product name was found different between these 3 pacemakers boxes.The root cause of the subject issue is due to a printing variability, the size is different between the template field and the image used for that field.In this case, the logo used is the same for two different fields but does not have the same field dimensions, creating this size mismatch.It should be noted that there is no patient safety risk associated to this non-conformance.The investigation results are retained and utilized for trending purposes.
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Event Description
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Reportedly, the labels were different between three pacemaker boxes, as the product name was not always printed at the same size.
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Search Alerts/Recalls
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