Model Number IPN041107 |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).
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Event Description
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It was reported that "during inflation test of the mask prior to use, it was impossible to deflate the mask".No patient involvement reported.
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Manufacturer Narrative
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Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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It was reported that "during inflation test of the mask prior to use, it was impossible to deflate the mask".No patient involvement reported.
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Event Description
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It was reported that "during inflation test of the mask prior to use, it was impossible to deflate the mask".No patient involvement reported.
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Manufacturer Narrative
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Qn#(b)(4).The sample was returned for evaluation.The sample was functionally tested and it was found that the device could be inflated and deflated with a syringe.No issues were encountered.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.The device functioned as intended.
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Search Alerts/Recalls
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