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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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: 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.
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 complaint: the customer reported that the wlan station (qi-430pa) attached to the bsm would not power on.The unit was sent in to the nka repair center for evaluation.The reported issue could not be duplicated at the repair center.There was no patient harm reported.Service requested / performed: repair / evaluation.Investigation summary: the root cause of this issue cannot be determined as the issue could not be duplicated during the evaluation.The device was functioning normally and was tested at the repair center.Since the root cause was unable to be determined, no capa is required.Without a root cause, the counter measure to prevent recurrence cannot be performed.The overall risk rating is medium.The following fields are not applicable (na) to the mdr report: b2 b6 b7 d4 lot # & expiration date d6a & d6b d7b f1 - f14 g4 device bla number g5 g7 h7 h9 the following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the bsm: cns: model #: ni serial #: ni wlan station: model #: qi-430pa serial #: (b)(6).Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.

• Brand Name: BSM-3552A
• Common Device Name: VITAL SIGN MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• MDR Report Key: 8848957
• Report Number: 8030229-2019-00326
• Device Sequence Number: 2730642
• 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
• Serviced by Third Party (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): 08/06/2021
• Report Date (Section F): 07/31/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/08/2019
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/06/2021
• 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: CNS.WLAN STATION.; CNS.WLAN STATION.; WLAN STATION.
• Date Report Sent to FDA: 07/31/2019