Model Number ARD515002964 |
Device Problems
Crack (1135); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Event site telephone: (b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
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Event Description
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On (b)(6) 2024 getinge became aware of an issue with one of surgical equipment - pendant.It was stated stated that during preventive maintenance the socket was found to be cracked and small part of the cover was missing.We decided to report the issue in abundance of caution as any particles which could fall off into sterile field or during procedure may cause contamination.As suggested by the technician the issue is probably caused by improper handling by customer.
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Search Alerts/Recalls
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