MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-2351A; VITAL SIGNS MONITOR

Model Number BSM-2351A

Device Problems No Display/Image (1183); Image Display Error/Artifact (1304); Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the bsm (bedside monitor) is showing lines and flickers, unit does turn on but is not able to show info on screen.The device was returned to nihon kohden and evaluated, but the reported issue cannot be duplicated.Unit is still being tested.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 when additional information becomes available.

Event Description

The customer reported that the bsm (bedside monitor) is showing lines and flickers, unit does turn on but is not able to show info on screen.

Manufacturer Narrative

Manufacturer narrative: the customer reported that the bsm (bedside monitor) is showing lines and flickers, unit does turn on but is not able to show info on screen.The device was returned to nihon kohden and evaluated, but the reported issue cannot be duplicated.Unit is still being tested.The reported problem still could not be duplicated after undergoing evaluation for an extended period of time.The customer requested the inverter board be replaced as a precautionary measure.The device has been repaired and returned to the customer.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: BSM-2351A
• Type of Device: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580 ; 2687488
• MDR Report Key: 5537002
• MDR Text Key: 41766584
• Report Number: 8030229-2016-00127
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/30/2016,02/29/2016

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
• Device Operator: Health Professional
• Device Model Number: BSM-2351A
• Device Catalogue Number: BSM-2351A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2016
• Distributor Facility Aware Date: 02/29/2016
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2016
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2005
• 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