The customer reported that "the hinged belt guard on lifeband (lot #161862) got broken" was confirmed during the visual inspection.The probable cause for the physical damage was appeared to be characteristics of a harsh impact due to mishandling.Upon visual inspection, it was observed that the autopulse lifeband hinged belt guard was broken off into two pieces, thus confirming the reported complaint.It is possible that the lifeband hinged belt guard was not flipped down and snapped into place fully before the platform was turned over and placed on the ground.Functional testing could not be performed due to the observed damage on the lifeband.Historical complaints were reviewed for information related to the reported complaint, and there was no similar complaint reported for lifeband with lot# 161862.
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During shift check, the customer installed lifeband#1 (lot #161862) to test the autopulse platform (sn (b)(4)).After performing a few compressions, the autopulse platform stopped working with an unusual sound and displayed an unknown error message.The customer observed that the fabric holding the lifeband band clip was torn, and the band clip was detached.The customer replaced it with another lifeband #2 (lot #161862) and restarted the platform.Shortly after compression, the hinged belt guard on lifeband got broken with an unusual sound.After the reported issue, the customer tested the autopulse platform with another lifeband, and the platform functioned as intended.No patient involvement.Please see the following related mfr report: mfr 3010617000-2022-00104 for the autopulse platform (sn (b)(4)).Mfr 3010617000-2022-00105 for the lifeband #1 (lot #161862).
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