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

Model Number BSM-2354A

Device Problems Image Display Error/Artifact (1304); Device Inoperable (1663)

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

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

Nihon (b)(4) continues to investigate the reported event.Nihon (b)(4) will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.Device evaluation is in progress.

Event Description

The customer reported that when the bsm (bedside monitor) is powered on, the display is white.All other features appear to be working.

Manufacturer Narrative

Additional manufacturer narrative: the device related to this complaint was returned and evaluated.Could not duplicate the customer reported problem.Bedside monitor was tested for a week.Unit was powered up numerous times from a cold start, and after the bedside monitor had been on for days.The repair center did not once see a white screen or a flicker.The monitor was opened to make sure all the cables had a good connection.The front case had to be replaced due to a broken screw insert.No malfunction was found.

• 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: 5325955
• MDR Text Key: 34939186
• Report Number: 8030229-2015-00464
• 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,Followup,Followup
• Report Date: 12/23/2015,11/23/2015

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: 12/08/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2015
• Distributor Facility Aware Date: 11/23/2015
• Device Age: 117 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2015
• Initial Date Manufacturer Received: 12/23/2015
• Initial Date FDA Received: 12/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/16/2016; 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2006
• 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