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

Model Number	CNS-9700A
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that there's no sound at central nurse's station (cns).There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported that there's no sound at central nurse's station (cns).The customer moved the audio cable and the sound cameback.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.The following fields are not available (n/a) to this report: email and telephone number.
Event or Problem Description
The customer reported that there's no sound at central nurse's station (cns).There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that there's no sound at central nurse's station (cns).The customer moved the audio cable and the sound cameback.There was no patient injury reported.Investigation summary: during troubleshooting, it was identified that when the audio cable was moved the audio came back on the cns.Although not definitive, it is likely that the audio cable is not properly inserted and is loose, or the audio cable is damaged.If the audio cable is loose, there will be no audio coming from the cns.It is also possible that a user had inadvertently loosen the audio 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 inadequate cable management.If the cable was properly connected, the issue would have not occurred.No corrective actions will be implemented at this time.Attempt # 1: (b)(6) 2022 a phone call was made in an attempt to gather patient and device information, i was transferred to kristin's voice mail and a message was left for her to call me back with the patient and device information and to please provide an email address.Attempt # 2: (b)(6) 2022 a phone call was made in an attempt to gather patient and device information, i was transferred to kristin's voice mail and a message was left for her to call me back with the patient and device information and to please provide an email address.Attempt # 3 (b)(6) 2022 a phone call was made in an attempt to gather patient and device information, i was transferred to kristin's voice mail and a message was left for her to call me back with the patient and device information and to please provide an email address.The following fields are not available (n/a) to this report: e1 email and telephone number.Manufacturer references # (b)(4).

• 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: 13654684
• Report Number: 8030229-2022-02552
• Device Sequence Number: 2519109
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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: 02/02/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.; NI.
• Patient Sex: Unknown