Model Number MODEL 100 |
Device Problems
Use of Device Problem (1670); Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2024 |
Event Type
malfunction
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Event Description
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The customer reported autopulse lifebands could not be secured in the back of the autopulse platform sn (b)(6).The lifeband does not line up with the clips.The customer tried two different lifebands with the same result.No device malfunction is suspected with the lifebands.No patient involvement.
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Manufacturer Narrative
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The reported complaint that autopulse lifebands could not be secured in the back of the autopulse platform sn (b)(6) was not confirmed during visual inspection or functional testing.The platform functioned appropriately and as intended.Zoll concluded that the root cause of the customer's reported complaint was related to an issue with the customer's lifeband.The lifeband returned with the platform was observed to be damaged, with a broken locking tab.However, the broken locking tab does not affect the functionality of the lifeband.During visual inspection, no physical damage was observed on the autopulse platform.The archive data review showed no significant discrepancies.The autopulse platform passed the initial functional testing without any fault or error.Following service, the autopulse platform passed the run-in test for 15 minutes without any fault or error.The autopulse platform passed the final testing without any fault or error.
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Manufacturer Narrative
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B5 (describe event or problem) was corrected.
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Event Description
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The customer reported autopulse lifebands could not be secured in the back of the autopulse platform (sn (b)(6).The lifeband does not line up with the clips.Per the customer, the lifeband performed as intended in other platforms.The customer tried two different lifebands with the same result.No device malfunction is suspected with the lifebands.The platform was still able to perform compressions.No patient involvement.
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Search Alerts/Recalls
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