Model Number MODEL 100 |
Device Problems
Break (1069); 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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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 # 3010617000-2023-00411 for the second lifeband.
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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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Manufacturer Narrative
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The reported complaint of "broken hinged guards and ripped tyvek liner" was confirmed during visual inspection of the returned lifeband (lot # 168928).The observed damages appeared to be an isolated instance of excessive force applied to the hinged belt guards of the lifeband.The reported complaint that "the band was jammed and twisted" was also confirmed during the visual inspection of the returned lifeband.The root cause of this observed issue could not be conclusively determined; however, user handling cannot be ruled out.During visual inspection, it was found that one side of the hinged belt guard was broken, and the protective cloth cover (tyvek liner) on both bands was partially detached from the hinged belt guards due to being forcibly ripped from its fixing points.The force was likely applied to the bands when they were pulled up.In addition, band 2 of the lifeband was partially twisted but had become untwisted at 4-5 inches further away from the hinged belt guards.The observed twisted band was not likely to cause damage to the lifeband.Functional testing could not be performed due to the observed damages on the returned 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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