MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION PU-621RA; CENTRAL MONITOR SYSTEM

Model Number CNS-6201A

Device Problems No Display/Image (1183); Device Inoperable (1663)

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

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that one of the monitors on his central nurses station (cns) went black.After troubleshooting the issue, the biomedical engineer stated that the main display also went black.He verified that everything was plugged in correctly, however, he was not able to power on the unit with just the dvi cable but was able to power the unit using the vga cable.The biomed attempted to extend the display to the secondary monitor using the vga cable but when attempting to apply the settings, nothing happened.The faulty dvi cable was swapped with a functioning dvi cable and the issue was resolved.When using the new dvi cable, the biomedical engineer stated that the configuration of the screens were not correct.Nihon kohden technical support assisted him in the configuration of his screens.

Event Description

The biomedical engineer reported that one of the monitors on his central nurses station (cns) went black.

• Brand Name: PU-621RA
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 6867105
• MDR Text Key: 86256072
• Report Number: 8030229-2017-00312
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 4931921114131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNS-6201A
• Device Catalogue Number: PU-621RA
• 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: 09/14/2017
• Distributor Facility Aware Date: 08/21/2017
• Device Age: 54 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2017
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2013
• 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