MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION BSM-2354A; VITAL SIGNS MONITOR

Model Number BSM-2354A

Device Problem Image Display Error/Artifact (1304)

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

Event Date 12/16/2015

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the bsm (bedside monitor) has intermittent display visibility.The device was returned to nihon kohden, evaluated, and the reported issue could not be duplicated.Tech support tested and ran the bedside for a week and half, and did not once encounter the screen intermittently go out.Also tested from a cold start and also while the bsm had been running for a few days.Completed all steps in the maintenance check sheet per service manual.Currently waiting to hear from the customer.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.

Event Description

The customer reported that the bsm (bedside monitor) has intermittent display visibility.

• Brand Name: BSM-2354A
• Type of Device: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 486 nanokaichi; tomioka city, japan 370-2 343; JA 370-2343
• Manufacturer (Section G): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; tokyo, japan 161-8 560; JA 161-8560
• Manufacturer Contact: thomas bento ; 1-31-4 nishiochia, shinjuku-ku; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687708
• MDR Report Key: 5356533
• MDR Text Key: 35923049
• Report Number: 8030229-2016-00014
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011918
• 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: 01/10/2016,12/16/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: BSM-2354A
• Device Catalogue Number: BSM-2354A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2016
• Distributor Facility Aware Date: 12/16/2015
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2016
• Initial Date Manufacturer Received: 01/10/2016
• Initial Date FDA Received: 01/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2006
• 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