MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-6700A; VITAL SIGN MONITOR

Model Number BSM-6700A

Device Problems No Display/Image (1183); Output Problem (3005); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reports device screen went blank during operation.The information on the screen slowly back came after one minute.This happened 4 times in the period of an hour and a half during a case.Customer is sending in the device for repair and the device was replaced with another working device and a loaner is being sent to the customer as well.No patient injury reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The biomedical engineer reports device screen went blank during operation.The information on the screen slowly back came after one minute.This happened 4 times in the period of an hour and a half during a case.Customer is sending in the device for repair and the device was replaced with another working device and a loaner is being sent to the customer as well.No patient injury reported.

Event Description

The biomedical engineer reports device screen went blank during operation.The information on the screen slowly back came after one minute.This happened 4 times in the period of an hour and a half during a case.Customer is sending in the device for repair and the device was replaced with another working device and a loaner is being sent to the customer as well.No patient injury reported.

Manufacturer Narrative

H10: additional narrative: on (b)(6) 2019, (b)(6) at (b)(6) hospital reported the bsm-6700a (mu-671ra sn: (b)(6) screen went black in the middle of an operation.The device screen slowly came up after one minute.Issue happened 4 times in the period of an hour and a half during a case.Device was not being monitored by any central stations.There was no patient data on the monitor to look at.Device was not tested by the biomed at the facility.Service requested: repair with loaner.Service performed: the unit was returned and evaluation confirmed the issue.The 15 inch lcd display was replaced to resolve the issue: 9000056672 lcd, mu-671ra (s/n: (b)(6) or later) 1 ea the unit completed extended testing and operated to manufacturer's specifications.Investigation result: the device warranty began 2018, which is almost 9 months at the time of reported issue.A review of device history found no previously reported issues with the display or device shutting off.A review of customer's complaints found no similarly reported issues with the bsm display.Additionally, nkc reviewed the mu-671ra relevant serials and found no problems with the manufacturing and assembly history.The root cause of the lcd failure could not be determined.Contributing factors include conditions of use, handling, and storage.Per bsm-6700a service manual, the lcd display is a replaceable part.Troubleshooting of the display and replacement of the lcd is addressed in the service manual.The issue was able to be resolved by replacing the lcd.The bsm was in use with a patient and there was no reported harm.The device was able to operate within specifications after servicing the unit.Supplement to investigation entered 06/03/2019: per nkc dhr (attached), 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.Further review of device sap history found no reported issues with the unit after return to customer on (b)(6) 2019.Corrected information: f9.Approximate age of device: incorrectly calculated.G4.Date received by manufacturer: should be 03/12/2019 not 04/10/2019 as listed on mdr initial report.Additional information: b4.Date of this report.D10.Device available for evaluation? f6.Date user facility/importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.Type of report.H2.If follow-up, what type? additional information.Correction.Device evaluation.H3.Device evaluated by manufacturer? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

• Brand Name: BSM-6700A
• Type of Device: 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: 8502017
• MDR Text Key: 141758216
• Report Number: 8030229-2019-00086
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921103562
• UDI-Public: 04931921103562
• Combination Product (y/n): N
• PMA/PMN Number: K080342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/09/2019

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
• Device Operator: Health Professional
• Device Model Number: BSM-6700A
• Device Catalogue Number: MU-671RA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2019
• Distributor Facility Aware Date: 08/09/2019
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2019
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 04/10/2019
• Supplement Dates Manufacturer Received: 08/09/2019
• Supplement Dates FDA Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1