MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION BSM-6300A; VITAL SIGNS MONITOR

Model Number BSM-6300A

Device Problems No Display/Image (1183); Device Emits Odor (1425); Failure to Power Up (1476); Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reports that the bedside monitor screen abruptly went out while monitoring patient vitals.The nurse reports smelling smoke.The clinical staff tried power cycling the bedside but the unit would not power back on.Unit was removed from service and evaluated.No patient harm was reported.There was no sign of burn marks or signs of fire.The cns (central nursing station) was monitoring the bedside monitor at the time the incident occurred.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.

Event Description

The customer reports that the bedside monitor screen abruptly went out while monitoring patient vitals.The nurse reports smelling smoke.The clinical staff tried power cycling the bedside but the unit would not power back on.Unit was removed from service and evaluated.No patient harm was reported.There was no sign of burn marks or signs of fire.The cns (central nursing station) was monitoring the bedside monitor at the time the incident occurred.

Manufacturer Narrative

Manufacturer narrative: the customer reported that the bedside monitor (bsm) display screen abruptly "went out" while monitoring patient vitals.The nurse also reported smelling smoke.The clinical staff tried to power cycle the bedside monitor (bsm), however the unit would not power back up.The central nurse's station (cns) was monitoring the bedside monitor (bsm) at the time the incident occurred and patient harm was reported.There were no indications of burn marks or fire.The unit was removed from service and sent to nihon kohden for evaluation and repair.The unit was cleaned and evaluated.The reported problem (display screen went out) was duplicated.Additionally, during the evaluation, deep scratches were found on the touchscreen.All malfunctioning parts were replaced.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 continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: BSM-6300A
• Type of Device: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer Contact: susan shadley ; 1-31-4 nishiochiai, shinjuku-k; attn: susan shadley; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687133
• MDR Report Key: 6298990
• MDR Text Key: 66677467
• Report Number: 8030229-2017-00024
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: 04931921103517
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080342
• 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
• Report Date: 02/02/2017,01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BSM-6300A
• Device Catalogue Number: MU-631RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2017
• Distributor Facility Aware Date: 01/10/2017
• Device Age: 28 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2017
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2014
• 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