MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION BSM-2301A; VITAL SIGNS MONITOR

Model Number BSM-2301A

Device Problem Failure to Power Up (1476)

Patient Problem No Information (3190)

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reports that the bsm (bedside monitor) went out during patient use.The bsm will not turn on.The customer believes the monitor was dropped.The device was returned for evaluation and repair.The reported problem with the unit not powering on could not be duplicated, however found noisy respiratory waveform and physical damage.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reports that the bsm (bedside monitor) went out during patient use.The bsm will not turn on.The customer believes the monitor was dropped.

• Brand Name: BSM-2301A
• Type of Device: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 486 nanokaichi; tomioka city, japan 370-2 343; JA 370-2343
• Manufacturer (Section G): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; tokyo, japan 161-8 560; JA 161-8560
• Manufacturer Contact: thomas bento ; 1-31-4 nishiochia, shinjuku-ku; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687708
• MDR Report Key: 6081875
• MDR Text Key: 59615048
• Report Number: 8030229-2016-00537
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011918
• 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: 11/04/2016,10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BSM-2301A
• Device Catalogue Number: BSM-2301A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2016
• Distributor Facility Aware Date: 10/05/2016
• Device Age: 157 MO
• Event Location: Other
• Date Report to Manufacturer: 11/04/2016
• Date Manufacturer Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2003
• 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