MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-9700A; CENTRAL MONITOR SYSTEM

Model Number	CNS-9700A
Medical Device Problem Codes	Device Alarm System (1012); No Audible Alarm (1019); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The nurse reported that they are not getting alarms from the nibp on the central nurse's station (cns).They stated that they are not getting any nibp alarms for patients above or below the set numbers of 170 / 80.They are requesting to have a clinical review of the alarm setting on this cns.One of the nurses in icu informed her that they do have the option to turn the alarms off.The nurse also stated that they would call up to the other departments to verify if they are changing these setting and reach back out to us.Tech support (ts) called for additional complaint information and was told all they know was that the issue is resolved, and they do not know how it was resolved.No patient harm was reported.
Additional Manufacturer Narrative
The nurse reported that they are not getting alarms from the nibp on the central nurse's station (cns).They stated that they are not getting any nibp alarms for patients above or below the set numbers of 170 / 80.They are requesting to have a clinical review of the alarm setting on this cns.One of the nurses in icu informed her that they do have the option to turn the alarms off.The nurse also stated that they would call up to the other departments to verify if they are changing these setting and reach back out to us.Tech support (ts) called for additional complaint information and was told all they know was that the issue is resolved, and they do not know how it was resolved.No patient harm was 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.
Additional Manufacturer Narrative
Investigation summary: the nurse reported that they are not getting alarms from the nibp on the central nurse's station (cns).They stated that they are not getting any nibp alarms for patients above or below the set numbers of 170 / 80.They are requesting to have a clinical review of the alarm setting on this cns.One of the nurses in icu informed her that they do have the option to turn the alarms off.The nurse also stated that they would call up to the other departments to verify if they are changing these setting and reach back out to us.Tech support (ts) called for additional complaint information and was told all they know was that the issue is resolved, and they do not know how it was resolved.No patient harm was reported.Investigation conclusion: customer reported that their cns was not alarming for nibp.Nurse indicated that they had an option to turn off the alarm.This suggests that there was the cns alarmed visually.The issue is likely regarding no sound or audible alarm.In a follow-up, customer indicated that the issue has been resolved.But the customer did not know how the issue was resolved.A review of the history of serial number identified no similar events.Based on the available information, a definitive root cause could not be identified.Audio alarms may not be audible when the volume is muted or is set to low volume, the audio cable is unplugged, or when the wrong audio output device is selected.If the audio settings of the device are correct and the cable is properly plugged, audio issues may still occur due to physical damage on the cable.Cable damage may occur due to normal wear and tear or due to human factors.Cables that are often disconnected and reconnected or are positioned in areas where they are in possible with other objects or persons are more susceptible to physical damage.Possible root causes for cable damage are normal wear and tear or mishandling.Correction: b2 required intervention to prevent permanent impairment/damage was marked in error in the initial mdr submitted and the check mark has been removed from the box.
Event or Problem Description
The nurse reported that they are not getting alarms from the nibp on the central nurse's station (cns).They stated that they are not getting any nibp alarms for patients above or below the set numbers of 170 / 80.They are requesting to have a clinical review of the alarm setting on this cns.One of the nurses in icu informed her that they do have the option to turn the alarms off.The nurse also stated that they would call up to the other departments to verify if they are changing these setting and reach back out to us.Tech support (ts) called for additional complaint information and was told all they know was that the issue is resolved, and they do not know how it was resolved.No patient harm was reported.

• Brand Name: CNS-9700A
• Common Device Name: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa,, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 14458706
• Report Number: 8030229-2022-02876
• Device Sequence Number: 17324012
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K023475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNS-9700A
• Device Catalogue Number: MU-971RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2006
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown