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

Model Number	BSM-3552A
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the bedside monitor (bsm) dropped out of network during patient monitoring activities.No consequence or impact to the patient was reported.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.The following devices were being used in conjunction with the bsm: cns no model and serial are not known as attempts to obtain information were made, but not provided qi-430pa (serial number: (b)(4)).
Event or Problem Description
It was reported that the bedside monitor (bsm) dropped out of network during patient monitoring activities.No consequence or impact to the patient was reported.
Additional Manufacturer Narrative
Details of the complaint: on (b)(6) 2019, customer at (b)(6) hospital reported the wlan station (qi-430pa sn: (b)(6) ) would not power on.The wlan station was connected to bedside monitor (bsm-3552a sn: (b)(6) ).There was an interruption in monitoring at the cns.Service requested/performed: the unit was cleaned and decontaminated.The model, serial number, and all labels were verified.Physical evaluation: no physical damage nor fluid intrusion.Verify the complaint: unit does not power up problem cannot be duplicated and all transmitted parameters are correctly display on the cns.Possible malfunctioned pcb or part(s): none the unit was tested per the operator's/service manual.The unit completed 24 hours of extended testing and operates to manufacturer's specifications.Investigation conclusion: based on the information provided in the complaint record, the bedside monitor was operating within specifications.No risk assessment is conducted as the reported issue is not suspected to involve a malfunction or deficiency of the device.Additional device information: d11 & c2: the following devices were being used in conjunction with the bsm: cns: model and serial are not known as attempts to obtain information were made, but not provided.Qi-430p: (serial number: (b)(6) ).
Event or Problem Description
It was reported that the bedside monitor (bsm) dropped out of network during patient monitoring activities.No consequence or impact to the patient was reported.

• 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: 8848908
• Report Number: 8030229-2019-00325
• Device Sequence Number: 2267675
• Product Code: MHX
• UDI-Device Identifier: 04931921113677
• UDI-Public: 04931921113677
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K080342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020
• Report Date (Section F): 02/11/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/10/2020
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CNSWLAN STATION; CNSWLAN STATION
• Date Report Sent to FDA: 02/11/2020