During patient use, the alignment tab of the lifeband (lot # 92272) got broken.The customer reported that the lifeband was in good condition before the alignment tab broke.However, the side of the lifeband, which was installed into the autopulse platform, showed excessive wear.Patient's status information was requested, but the customer did not provide a response; therefore, patient's status is unknown.
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The lifeband (lot # 92272) was returned for evaluation; however, testing could not be performed due to the observed contamination.Moreover, the lifeband was cut by the customer prior to the return, and therefore, no further testing could be performed.Nevertheless, the reported complaint of "the alignment tab of the lifeband (lot # 92272) got broken" was confirmed based on the provided pictures from the customer.This type of damage can occur during user handling when the lifeband is not closed properly per user manual.Per autopulse system user guide, to properly align the two sides of the lifeband: place band 1 on top of patient's chest, locate mating slot of band 2 over the alignment tab 1, press the bands together to engage and secure the velcro fastener, lift up the lifeband to its fullest extension, ensuring that the side bands are at a 90 degree angle to the platform, that they are not twisted and that there are no obstructions and center the lifeband on the patient's chest, placing it such that its center is over the area upon which manual compressions are conducted.Failure to follow the above instructions results can damage or break the lifeband.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaint reported for lifeband with lot # 92272.
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