MAUDE Adverse Event Report: NIHON KOHDEN DIGITAL HEALTH SOLUTIONS CENTRAL MONITORING SYSTEM; CENTRAL MONITORING STATION

Model Number A-WSS-002-ZA

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2022

Event Type  malfunction  

Event Description

The customer reported that the gz telemetry transmitter has been dropped off the wireless surge system (a-wss-002-za) and wants to add it back to the system.It is unclear if the user removed the gz transmitter from the wireless surge system or if the gz transmitter dropped of the wireless surge system without user intervention as the customer.Qa has asked the customer to provide clarification on this matter, but they have been unresponsive.Therefore, to err on the side of caution, qa is reporting this as an mdr.No patient harm was reported.

Manufacturer Narrative

The customer reported that the gz telemetry transmitter has been dropped off the wireless surge system (a-wss-002-za) and wants to add it back to the system.It is unclear if the user removed the gz transmitter from the wireless surge system or if the gz transmitter dropped of the wireless surge system without user intervention as the customer.Qa has asked the customer to provide clarification on this matter, but they have been unresponsive.Therefore, to err on the side of caution, qa is reporting this as an mdr.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.Attempt #1 02/11/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 02/17/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 02/18/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: d10: concomitant medical device: the following device(s) were being used in conjunction with the a-wss-002-za.Telemetry transmitter: model: gz-130pa.Sn: (b)(4).

Manufacturer Narrative

Details of complaint: the customer reported that the gz telemetry transmitter had dropped off the wireless surge system (a-wss-002-za) and they wanted to add it back to the system.It was unclear if the user removed the gz transmitter from the wireless surge system or if it dropped of the wireless surge system without user intervention.No patient harm was reported.Details of complaint: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.A serial number review of the reported device does not reveal additional related complaints.Multiple attempts were made to obtain additional information from the customer, but these requests did not yield any answers.A possible root cause may be related to unintentional removal of the device from the network or hospital network environment issues.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the monitor (a-wss-002-za): gz transmitter: model #: gz-130pa.Serial #: (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.

Event Description

The customer reported that the gz telemetry transmitter had dropped off the wireless surge system (a-wss-002-za) and they wanted to add it back to the system.It was unclear if the user removed the gz transmitter from the wireless surge system or if it dropped of the wireless surge system without user intervention.No patient harm was reported.

• Brand Name: CENTRAL MONITORING SYSTEM
• Type of Device: CENTRAL MONITORING STATION
• Manufacturer (Section D): NIHON KOHDEN DIGITAL HEALTH SOLUTIONS; attn: shama mooman; 14 bunsen; irvine CA 92618
• Manufacturer (Section G): NIHON KOHDEN DIGITAL HEALTH SOLUTIONS; 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: 13715228
• MDR Text Key: 296961901
• Report Number: 2032233-2022-02634
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 00841983104336
• UDI-Public: 00841983104336
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A-WSS-002-ZA
• Device Catalogue Number: A-WSS-002-ZA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: GZ-130PA (B)(6).; TRANSMITTER GZ-130PA (B)(6).