Model Number PARADYM DR 8550 |
Device Problems
Defibrillation/Stimulation Problem (1573); Low impedance (2285)
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Patient Problem
Atrial Fibrillation (1729)
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Event Date 02/12/2015 |
Event Type
Injury
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Event Description
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During a scheduled patient follow-up (for cardioversion purpose), the user programmed an induction shock at 20j from the eps screen, but the shock was not delivered (the patient did not feel the shock) and the atrial fibrillation was still observed.A warning message was displayed to the user stating that ¿low shock impedance.Defibrillation system ineffective¿.Three more attempts with maximum energy shock (at 42j) had failed again because of overload phenomenon.It should be noted that all impedance and continuity measurements were normal and the battery was still far from elective replacement indicator (eri at 2.66v).Recommendations were provided in order to evaluate the benefit of the lead replacement as well as the good functioning of the subject device.It was then reported that the device was replaced (and the associated lead was capped) on (b)(6) 2015 and will be returned for analysis.
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Event Description
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During a scheduled patient follow-up (for cardioversion purpose), the user programmed an induction shock at 20j from the eps screen, but the shock was not delivered (the patient did not feel the shock) and the atrial fibrillation was still observed.A warning message was displayed to the user stating that ¿low shock impedance.Defibrillation system ineffective¿.Three more attempts with maximum energy shock (at 42j) had failed again because of overload phenomenon.It should be noted that all impedance and continuity measurements were normal and the battery was still far from elective replacement indicator (eri at 2.66v).Recommendations were provided in order to evaluate the benefit of the lead replacement as well as the good functioning of the subject device.It was then reported that the device was replaced (and the associated lead was capped) on (b)(4) 2015 and will be returned for analysis.
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Manufacturer Narrative
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Preliminary analysis of the returned device showed that the electrical characteristics of the returned unit are within specifications.
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Event Description
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During a scheduled patient follow-up (for cardioversion purpose), the user programmed an induction shock at 20j from the eps screen, but the shock was not delivered (the patient did not feel the shock) and the atrial fibrillation was still observed.A warning message was displayed to the user stating that ¿low shock impedance.Defibrillation system ineffective¿.Three more attempts with maximum energy shock (at 42j) had failed again because of overload phenomenon.It should be noted that all impedance and continuity measurements were normal and the battery was still far from elective replacement indicator (eri at 2.66v).Recommendations were provided in order to evaluate the benefit of the lead replacement as well as the good functioning of the subject device.It was then reported that the device was replaced (and the associated lead was capped) on (b)(6) 2015 and will be returned for analysis.
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Manufacturer Narrative
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Please refer to the attached report.
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Search Alerts/Recalls
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