Model Number ORG-9110A |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that this org has defective receiver cards and they want to send in the unit to be repaired.Technical support (ts) informed the customer that a po will be required as the unit is out of warranty.There was no patient injury reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.
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Event Description
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The customer reported that this org has defective receiver cards and they want to send in the unit to be repaired.There was no patient injury reported.
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Event Description
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The customer reported that the multi patient receiver (org) had defective receiver cards and they wanted to send the unit in for repair.There was no patient injury reported.
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Manufacturer Narrative
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Details of complaint: the customer reported that the multi patient receiver (org) had defective receiver cards and they wanted to send the unit in for repair.No patient harm was reported.Investigation summary: the reported device was sent in for repair.During the evaluation of the reported device, nihon kohden repair center (nk rc) was able to confirm the reported issue of defective receiver cards.Failure of receiver cards is likely a result of hardware failure.Hardware failure could come as a result of physical damage, heat damage, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Heat damage could occur due to improper maintenance or device placement.Electrical damage could occur during a power outage or power surge.Wear and tear due to aging or frequency of use can gradually degrade components.The org was installed in 9/2012 with no history of previous complaints or servicing.The root cause is likely related to aging of the device.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided.Attempt # 1: (b)(6) 2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating that it's hard to answer all the questions as this issue has been happening intermittently all over that floor with different patients at different times.Additional information: b4 date of this report.D9 device available for evaluation? g3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes.H10 additional manufacturer narrative.
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Event Description
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The customer reported that the multi patient receiver (org) had defective receiver cards and they wanted to send the unit in for repair.There was no patient injury reported.
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Manufacturer Narrative
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Udi related data quality updates.Corrected information: d4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the pi information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a.
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Search Alerts/Recalls
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