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

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.

• 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
• MDR Report Key: 13057102
• MDR Text Key: 285610817
• Report Number: 2080783-2021-02137
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/21/2021

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2021
• Distributor Facility Aware Date: 11/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRANSMITTER