MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-3552A; VITAL SIGN MONITOR

Model Number	BSM-3552A
Medical Device Problem Codes	Failure to Analyze Signal (1539); Device Issue (2379); Device Operational Issue (2914); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nurse called to ask questions about the bedside monitor (bsm) spo2 settings.She reported that another nurse was complaining that the spo2 did not alarm when the value dropped below the preset.She checked the values and the spo2 alarm values were correct.She will have the biomedical engineer (bme) check the bsm on a simulator.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.
Event or Problem Description
The nurse called to ask questions about the bedside monitor (bsm) spo2 settings.She reported that another nurse was complaining that the spo2 did not alarm when the value dropped below the preset.
Event or Problem Description
The nurse called to ask questions about the bedside monitor (bsm) spo2 settings.She reported that another nurse was complaining that the spo2 did not alarm when the value dropped below the preset.
Additional Manufacturer Narrative
Details of the complaint on (b)(6) 2018, customer at (b)(6) medical center reported the bedside monitor (bsm-3552a sn: (b)(6)) did not alarm when the spo2 value dropped below the preset.The spo2 alarm values were verified to be correct (high-off, low-89).Service requested troubleshooting/assistance.Service performed customer was advised to check the alarm with a simulator, and if it does not alarm, reach out to nk.After multiple follow up attempts were made, customer reported "all has been resolved" however no further information was provided.Investigation results per nkc dhr, the unit has had no history of ncmr, deviation, or capa during manufacturing of the device.The device has not been refurbished and there were no discrepancies or unusual findings before device release that might relate to the reported issue.The unit was delivered to customer facility on 01/22/18, and the issue was reported after approximately 4 months.Review of device sap history found no other reported issues for the unit.Review of tickets opened at customer facility found no similarly reported issues with "spo2" or "alarm".The reported issue was not confirmed by customer due to lack of information provided, nor at nka as the unit was not returned.No further issues have been reported for this unit.Review of customer's complaints found no adverse trend for this issue.From the information available, the root cause could not be determined.

• Brand Name: BSM-3552A
• Common Device Name: VITAL SIGN MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 7606224
• Report Number: 8030229-2018-00210
• Device Sequence Number: 217835
• Product Code: MHX
• UDI-Device Identifier: 04931921113677
• UDI-Public: 04931921113677
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K080342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019
• Report Date (Section F): 10/28/2019

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
• Operator of Device: Health Professional
• Device Model Number: BSM-3552A
• Device Catalogue Number: BSM-3552A
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/25/2019
• Device Age: 21 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT APPLICABLE
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT APPLICABLE.
• Date Report Sent to FDA: 10/28/2019