Model Number PLATINIUM DR 1540 |
Device Problem
Failure to Transmit Record (1521)
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Patient Problem
No Information (3190)
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Event Date 07/02/2019 |
Event Type
malfunction
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Event Description
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Reportedly, the associated home monitor is properly paired to the subject defibrillator, but no remote follow-up can be performed on the patient.Additionally, a new home monitor has been shipped to the patient, but the same behavior was observed.
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Event Description
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Reportedly, the associated home monitor is properly paired to the subject defibrillator, but no remote follow-up can be performed on the patient.Additionally, a new home monitor has been shipped to the patient, but the same behavior was observed.
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Manufacturer Narrative
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Please refer to the attached preliminary analysis report.
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Manufacturer Narrative
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The complaint was re-opened following the reception of additional information: on (b)(6) 2020, the patient came to the hospital and a third home monitor was provided and tested on site.The home monitor could correctly be paired to the subject icd.However, no patient initiated transfer (pit) could be performed, even if the home monitor stayed at the same distance from the patient, as for when the pairing was performed: the progression lights of the home monitor were lighting in green, but then the pit button started blinking in red.The rf from the icd was deactivated, then reactivated, but the observed behavior persisted.All electrical devices that were close to the home monitor and the icd were off, and the network was observed to be properly working.
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Event Description
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Reportedly, the associated home monitor is properly paired to the subject defibrillator, but no remote follow-up can be performed on the patient.Additionally, a new home monitor has been shipped to the patient, but the same behavior was observed.
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Manufacturer Narrative
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Preliminary analysis revealed that the observed impossibility to perform a patient initiated transfer (pit) or remote follow-ups most probably resulted from an issue with the data transmitted by the implant to any home monitor, leading to the abortion of all the attempted communications.
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Event Description
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Reportedly, the associated home monitor is properly paired to the subject defibrillator, but no remote follow-up can be performed on the patient.Additionally, a new home monitor has been shipped to the patient, but the same behavior was observed.
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Event Description
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Reportedly, the associated home monitor is properly paired to the subject defibrillator, but no remote follow-up can be performed on the patient.Additionally, a new home monitor has been shipped to the patient, but the same behavior was observed.
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Manufacturer Narrative
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Please refer to the attached analysis report.
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Search Alerts/Recalls
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