MAUDE Adverse Event Report: DIGITAL HEALTH SOLUTIONS, INC. CENTRAL MONITORING SYSTEM; CENTRAL MONITORING STATION

Model Number	EDNS-9001
Medical Device Problem Codes	No Audible Alarm (1019); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that there's no sound coming out of this unit.According to the customer, there's an audio cable that works like a kvm aux repeater box.They use this to send the sound out to the screens on the hallway.When adjusting the volume slider, the sound is only heard in the hallway screens.Usually, the sound/alarm is heard at both the hallway and the prefence system.The customer will upgrade as the prefence is discontinued.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 contain no information (ni), as attempts to obtain information were made, but not provided: patient information: attempt # 1: 02/22/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/28/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 03/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Relevant tests and laboratory data: attempt # 1: 02/22/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/28/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 03/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Other relevant history: attempt # 1: 02/22/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/28/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 03/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Concomitant medical products: attempt # 1: 02/22/2023 emailed the customer via microsoft outlook for patient & device information: no reply was received.Attempt # 2: 02/28/2023 emailed the customer via microsoft outlook for patient & device information: no reply was received.Attempt # 3 03/07/2023 emailed the customer via microsoft outlook for patient & device information: no reply was received.The following is not available (n/a) to this report: device manufacture date.
Event or Problem Description
The customer reported that there's no sound coming out of this unit.There was no patient injury reported.
Event or Problem Description
The customer reported that there's no sound coming out of this unit.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that there's no sound coming out of this unit.According to the customer, there's an audio cable that works like a kvm aux repeater box.They use this to send the sound out to the screens on the hallway.When adjusting the volume slider, the sound is only heard in the hallway screens.Usually, the sound/alarm is heard at both the hallway and the prefence system.The customer will upgrade as the prefence is discontinued.There was no patient injury reported.Investigation summary: the customer was informed that the prefense system has already been discontinued.A review of the history of the serial number identified no previous complaints against the device.Based on the available information, a definitive root cause could not be identified.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 02/22/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/28/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 03/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 02/22/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/28/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 03/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 02/22/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 02/28/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 03/07/2023 emailed the customer via microsoft outlook for patient information: no reply was received.D10 attempt # 1: 02/22/2023 emailed the customer via microsoft outlook for patient & device information: no reply was received.Attempt # 2: 02/28/2023 emailed the customer via microsoft outlook for patient & device information: no reply was received.Attempt # 3 03/07/2023 emailed the customer via microsoft outlook for patient & device information: no reply was received.The following fields are not available (n/a) to this report: additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h10 additional manufacturer narrative.Manufacturer references # (b)(4).

• Brand Name: CENTRAL MONITORING SYSTEM
• Common Device Name: CENTRAL MONITORING STATION
• Manufacturer (Section D): DIGITAL HEALTH SOLUTIONS, INC.; attn: shama mooman; 14 bunsen; irvine CA 92618
• Manufacturer (Section G): DIGITAL HEALTH SOLUTIONS, INC.; attn: shama mooman; 14 bunsen; irvine CA 92618
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama, CA 359-8-580 ; JA 359-8580 ; 9492687488
• MDR Report Key: 16518346
• Report Number: 2032233-2023-03360
• Device Sequence Number: 3354017
• Product Code: DRG
• UDI-Device Identifier: 00851725007023
• UDI-Public: 00851725007023
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K102106
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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: EDNS-9001
• Device Catalogue Number: EDNS-9001
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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