MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6201; CENTRAL MONITOR SYSTEM

Device Problems Image Display Error/Artifact (1304); Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

Error messages indicative of a hard drive (hdd) failure.Defective device requested for repair and failure investigation.

Manufacturer Narrative

Manufacturer narrative: the central monitoring system (cns)will not display patient data for the telemetry patients being monitored.On the primary display, there is an error code "memory cannot be read." on the secondary screen, where patient being monitored the tiles are greyed out where patient data should be.Error messages indicative of a hard drive (hdd) failure.The customer was sent a loaner to resolve the issue.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: CNS-6201
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan 161-8 560; JA 161-8560
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgm; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580 ; 2687488
• MDR Report Key: 4143659
• MDR Text Key: 4789584
• Report Number: 8030229-2014-00038
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Remedial Action: Other
• Type of Report: Initial,Followup

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 08/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1