MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION; CENTRAL MONITOR SYSTEM

Device Problem Power Problem (3010)

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

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

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.Additional device information: concomitant medical device: the following device was used in conjunction with the cns: transmitter: model #: zm-520pa, serial #: (b)(4), device manufacturer data: 07/17/2012, unique identifier (udi) #: (b)(4).

Event Description

The customer reported that their facility experienced a power surge after which their central nurse's station (cns) went down.They were unable to load into the application and were getting "monitor network disconnect" error.No harm or injury was reported.

Manufacturer Narrative

Details of complaint: the customer reported that the facility experienced a power surge after which the central nurse's station (cns) went down.The unit was unable to load back into the cns application and was giving a "monitor network disconnect" error message.No patient harm was reported.Investigation summary: the customer was advised that the power surge likely caused the switches in the facility's closet to get powered off.Switches are used to allow multiple devices to connect over a network.The customer was able to confirm that the switches were powered off but were not able to power them on.The power surge likely caused damage to the switches.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.The root cause is likely related to environmental factors and not a result of a device deficiency.A complaint history review of the customer's account does not reveal trends for similar complaints.The following fields contains no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6 patient information.B6 - b7 adverse event or product problem.D1 brand name.D4 model name.Catalog name.Serial number.Unique identifier (udi) number.E1 email address.G4 pma/510(k) number.H4 device manufacturer date.Attempt #1 12/08/2021 called customer via the provided telephone number for all items under the no information section.No reply was received.Attempt #2 12/12/2021 called customer via the provided telephone number for all items under the no information section.No reply was received.Attempt #3 12/21/2021 called customer via the provided telephone number for all items under the no information section.No reply was received.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the cns: transmitter: model #: zm-520pa.Serial #: (b)(6).Device manufacturer data: 07/17/2012.Unique identifier (udi) #: (b)(4).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 facility experienced a power surge after which the central nurse's station (cns) went down.The unit was unable to load back into the cns application and was giving a "monitor network disconnect" error message.No harm or injury was reported.

• Brand Name: NI
• Type of Device: 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 ; 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: 13057093
• MDR Text Key: 282715960
• Report Number: 8030229-2021-02137
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: TRANSMITTER.; TRANSMITTER.