MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION MU-971RA; CENTRAL MONITOR SYSTEM (CNS-9700A)

Model Number	MU-971RA
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the patient data from different patients is being sent to another patients emr record.In the emr for bed 1013 in group icu-2 mrn: (b)(6), the a-line and the art line are coming from a different patient who is not on this bed.They do not know where it is coming from and neither does the nurse.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the patient data from different patients is being sent to another patients emr record.In the emr for bed 1013 in group icu-2 mrn: (b)(6), the a-line and the art line are coming from a different patient who is not on this bed.They do not know where it is coming from and neither does the nurse.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.The following fields contains no information (ni), as an attempt to obtain the information were made, but none were provided.Attempt #1: (b)(6) 2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: (b)(6) 2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: (b)(6) 2022 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the patient information as requested.Additional device information: concomitant medical device: the following devices were being used in conjunction with the cns.Bedside monitor 1013.Model: (b)(4), sn: (b)(4).Bedside monitor 1015.Model: (b)(4), sn: (b)(4).
Event or Problem Description
The customer reported that patient data from one patient (a-line and art lines) were sent to another patient's emr record.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that patient data from one patient (a-line and art lines) was sent to another patient's emr record.No patient harm was reported.Investigation summary: the issue of the vitals getting mixed up in the customer's emr was resolved after disabling the zm-view setting on the bedsides.Zm-view is used to monitor patients on telemetry devices.As the patients in this event were not reported to be connected to telemetry devices, it was likely that having this option on while not being used was causing interference with the reported bedsides.The root cause is related to incorrect settings and possible use error or workflow issues.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal similar complaints.Additional device information: d10: concomitant medical device: the following devices were used in conjunction with the cns: bedside monitor 1013: model: bsm-6701a sn: (b)(6).Bedside monitor 1015: model: bsm-6701a sn: (b)(6).Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative corrected information: e2: health professional? corrected the selection to "no.".
Event or Problem Description
The customer reported that patient data from one patient (a-line and art lines) were sent to another patient's emr record.No patient harm was reported.
Additional Manufacturer Narrative
Udi related data quality updates: d1 brand name: corrected the brand name from cns-9700a to mu-971ra.D4 additional device information / model #: corrected the model # from cns-9700a to mu-971ra.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.

• Brand Name: MU-971RA
• Common Device Name: CENTRAL MONITOR SYSTEM (CNS-9700A)
• 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 ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 14048750
• Report Number: 8030229-2022-02728
• Device Sequence Number: 12269943
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: (01)04931921000663(21)677
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2024

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: MU-971RA
• Device Catalogue Number: MU-971RA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 11/27/2023; 11/27/2023
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 11/28/2023; 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2006
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2 BSMS (BSM-6701A).; 2 BSMS (BSM-6701A).; BSM-6701A SN (B)(6).; BSM-6701A SN (B)(6).
• Patient Sex: Unknown