Model Number MODEL 100 |
Device Problems
Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Zoll has not received the lifeband in complaint for investigation.A follow-up report will be submitted if and when the product is returned, and an investigation has been completed.
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Event Description
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The customer reported that during the strenuous effort to position the patient on the x-ray table, the lifeband (lot # unknown) broke apart.The customer sent pictures showing that one of the hinged guards of the lifeband cover plate was broken.The tyvek liner was ripped, and the band was jammed and twisted.While installing the second lifeband (lot # unknown), the band locking clip broke.The customer continued the resuscitation attempt with manual cpr.No consequences or impacts on the patient.Please see the following related mfr report: mfr # 3010617000-2023-00397 for the first lifeband.
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Manufacturer Narrative
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The reported complaint of "broken band locking clip" was confirmed during visual inspection of the returned lifeband (lot # 168928).One side of the lifeband locking tabs was observed loose as the locking pin was pushed away from the body of the lifeband cover plate, likely attributed to the lifeband storage conditions by the user.No other physical damage was observed on the lifeband.Functional testing was not performed, as the locking tabs do not affect the functionality of the lifeband.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaints reported for lifeband with lot# 168928.
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Event Description
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The customer reported that during the strenuous effort to position the patient on the x-ray table, the lifeband (lot # 168928) broke apart.The customer sent pictures showing that one of the hinged guards of the lifeband cover plate was broken, the tyvek liner was ripped, and the band was jammed and twisted.While installing the second lifeband (lot # 168928), the band locking clip broke.The customer continued the resuscitation attempt with manual cpr.No consequences or impacts on the patient.
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Search Alerts/Recalls
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