MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION BSM 4100 SERIES; VITAL SIGNS MONITOR

Model Number BSM-4103A

Device Problem Device Inoperable (1663)

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

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reports that the lcd on the bedside monitor is dim and patient vitals were not visible on the monitor.The device was returned for evaluation and repair.The unit was cleaned and evaluated.The reported problem of "lcd dim" was duplicated.All malfunctioning parts were replaced and installed new battery.The unit was tested per operator's/service manual and the results were recorded on the maintenance check sheet.The unit completed 3 hours of extended testing and operates to manufacturer's specifications.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 when additional information becomes available.

Event Description

The customer reports that the lcd is really dim on the bedside side monitor.

• Brand Name: BSM 4100 SERIES
• Type of Device: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; 1-31-4 nishiochiai, shinjuku-k; attn: shama mooman; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687488
• MDR Report Key: 6357395
• MDR Text Key: 68362341
• Report Number: 8030229-2017-00051
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001693
• 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: 02/24/2017,01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BSM-4103A
• Device Catalogue Number: BSM-4103A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2017
• Distributor Facility Aware Date: 01/25/2017
• Device Age: 134 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2017
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2005
• 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
• Patient Outcome(s): Other