MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-5136A; VITAL SIGNS MONITOR

Model Number BSM-5136A

Device Problem Calibration Problem (2890)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the bedside monitor (bsm) gas bench is displaying a calibration error.Device was in use on patient but no patient harm reported.Nihon kohden continues to investigate the reported event.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.Lot number, expiration, and udi number was listed as na as this device was manufactured before the udi requirement.Concomitant medical device as no additional devices were being used.

Event Description

The biomedical engineer (bme) reported that the bedside monitor (bsm) gas bench is displaying a calibration error.Device was in use on patient but no patient harm reported.

Manufacturer Narrative

Details of complaint: on (b)(6) 2019, the customer at adventist health bakersfield (b)(6) reported the bedside monitor (bsm-5136a (b)(6) ) displayed a cal gas error.Service requested/performed: nka technical support (ts) advised the customer the unit was end of life.Investigation summary: the unit was not returned and no nka evaluation was not performed.There is insufficient information available to determine the root cause.Approximate age of the unit is 14 years.Possible root cause may be normal deterioration of the unit's parts.Investigation determined the issue poses low risk.

Event Description

The biomedical engineer (bme) reported that the bedside monitor (bsm) gas bench is displaying a calibration error.Device was in use on patient but no patient harm reported.

• Brand Name: BSM-5136A
• Type of Device: VITAL SIGNS 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: 9555761
• MDR Text Key: 188836627
• Report Number: 8030229-2020-00011
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K030105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/06/2020,11/13/2020

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
• Device Operator: Health Professional
• Device Model Number: BSM-5136A
• Device Catalogue Number: BSM-5136A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2020
• Distributor Facility Aware Date: 12/10/2019
• Device Age: 178 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2020
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 08/16/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1