Model Number 758000 |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885); Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/30/2014 |
Event Type
malfunction
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Event Description
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A user facility reported to us that "battery won't hold charge, won't run on battery and or can't charge battery" on (b)(6) 2014.There was no patient involvement, and the incident did not result in a delay of treatment.The device was evaluated on 05/30/2014 and it was noted that the device had a battery that would not hold a charge.Our risk document classifies the severity of a damaged diaphragm as "potentially requiring medical intervention to prevent permanent impairment of a body function or permanent damage to a body structure".We are obtaining further clinical evaluation of the risk of this failure and will provide follow up to this report once obtained.
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Manufacturer Narrative
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This is a follow up to corrected report submitted on 02/23/2016: clinical assessment of the failure mode "battery will not a charge" has been obtained and it has been determined that this occurence does not represent a reportable malfunction due to no evidence existing to reasonably suggest that the malfunction would be likely to cause or contribute to death or serious injury if it were to recur.
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Event Description
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This is a follow up to corrected report submitted on 02/23/2016: clinical assessment of the failure mode "battery will not a charge" has been obtained and it has been determined that this occurence does not represent a reportable malfunction due to no evidence existing to reasonably suggest that the malfunction would be likely to cause or contribute to death or serious injury if it were to recur.
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Manufacturer Narrative
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A user facility reported to us that "battery won't hold charge, won't run on battery and or can't charge battery" on (b)(6) 2014.There was no patient involvement, and the incident did not result in a delay of treatment.The device was evaluated on 05/30/2014 and it was noted that the device had a battery that would not hold a charge.Initial review of the complaint deemed the incident as not reportable because the failure mode was not considered to be likely to cause a serious injury or death should it recur.An external review of the complaint and the risk management documentation identified this complaint as reportable based on our risk assessment which classifies the severity of "dead battery" as "complete loss of performance, may result in permanent impairment or serious injury or death." we are obtaining further clinical assessment of the risk of this failure mode as well as evaluating the risk management documentation and will provide follow up to this report once the assessment is completed.
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Event Description
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A user facility reported to us that "battery won't hold charge, won't run on battery and or can't charge battery" on (b)(6) 2014.There was no patient involvement, and the incident did not result in a delay of treatment.The device was evaluated on 05/30/2014 and it was noted that the device had a battery that would not hold a charge.Initial review of the complaint deemed the incident as not reportable because the failure mode was not considered to be likely to cause a serious injury or death should it recur.An external review of the complaint and the risk management documentation identified this complaint as reportable based on our risk assessment which classifies the severity of "dead battery" as "complete loss of performance, may result in permanent impairment or serious injury or death." we are obtaining further clinical assessment of the risk of this failure mode as well as evaluating the risk management documentation and will provide follow up to this report once the assessment is completed.
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Search Alerts/Recalls
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