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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DIGITAL HEALTH SOLUTIONS, INC. CENTRAL MONITORING SYSTEM; CENTRAL MONITORING STATION
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DIGITAL HEALTH SOLUTIONS, INC. CENTRAL MONITORING SYSTEM; CENTRAL MONITORING STATION Back to Search Results
Model Number EDNS-9001
Device Problems Device Alarm System (1012); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2023
Event Type  malfunction  
Event Description
The biomedical engineer (bme) reported that the o2 alarms were not working on the prefense system, so they rebooted it.However, the unit never came back up, and they got a message saying that the boot up cannot find disk.No patient harm was reported.
 
Manufacturer Narrative
The biomedical engineer (bme) reported that the o2 alarms were not working on the prefense system, so they rebooted it.However, the unit never came back up, and they got a message saying that the boot up cannot find disk.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.Telemetry transmitter(s): model: ni.Sn: ni.
 
Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the o2 alarms were not working on the prefense system (g9 monitor).When trying to reboot the system, they received a boot up error and the system would not fully boot back up.No patient harm was reported.Investigation summary: customer indicated that they rebooted the system to troubleshoot the issue of the o2 alarms not working, however, the device would no longer boot up.The device had been in service since 11/30/2012.The prefense system had already been discontinued and is in end of life/service.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.Since the device is already in end of life/service, it is possible that an internal hardware component (i.E., power supply, hdd) of the device may have failed due to wear and tear and had contributed to the device not booting up and the o2 alarm not functioning properly.Other possible causes of the device not alarming is incorrect alarm settings, audio related issues (audio cable, settings, volume), and long uptime of the device without a reboot.The issue is regarding a product that is already discontinued.No corrective actions would be performed.Telemetry transmitter(s) model: ni 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? h3 device evaluated by manufacturer? h4 device manufacturer date h6 event problem and evaluation codes h10 additional manufacturer narrative.
 
Event Description
The biomedical engineer (bme) reported that the o2 alarms were not working on the prefense system.When trying to reboot the system, they received a boot up error and the system would not fully boot back up.No patient harm was reported.
 
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Brand Name
CENTRAL MONITORING SYSTEM
Type of Device
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 Key16561116
MDR Text Key312217533
Report Number2032233-2023-03345
Device Sequence Number1
Product Code DRG
UDI-Device Identifier00851725007023
UDI-Public00851725007023
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 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
Device Operator Health Professional
Device Model NumberEDNS-9001
Device Catalogue NumberEDNS-9001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/14/2023
Initial Date FDA Received03/16/2023
Supplement Dates Manufacturer Received06/06/2023
Supplement Dates FDA Received06/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
TELEMETRY TRANSMITTERS; TELEMETRY TRANSMITTERS
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