MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-2304A; VITAL SIGNS MONITOR

Model Number BSM-2304A

Device Problems Overheating of Device (1437); Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the bedside monitor (bsm) will not charge on a new battery and that the network port is overheating.They also said that the bsm gives an spo2 error.They ordered new batteries and the bsm still does not charge.They also tried swapping out the network card and it is still getting hot.No patient harm was reported.It was decided that the ip, sub, and gw will be configured on-site.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 customer reported that the bedside monitor (bsm) will not charge on a new battery and that the network port is overheating.They also said that the bsm gives an spo2 error.

Event Description

The customer reported that the bedside monitor (bsm) will not charge on a new battery and that the network port is overheating.They also said that the bsm gives an spo2 error.

Manufacturer Narrative

H10: additional narrative: (b)(6) reported on (b)(6) 2018 that their bsm-2304a (sn: (b)(6)) was displaying an spo2 error, would not charge with a new battery, and the network port was overheating.Service requested: repair/loaner.Service performed: repair/loaner.The unit was cleaned and evaluated.The reported problem "spo2 error, battery will not charge on new battery" was duplicated.Unit received with the following parts damaged: right and left side covers; front and rear covers; and battery was dead (did not charge).While troubleshooting the bedside, we encountered the following issues: bad resp; press 1; and nibp bad output waveform.Replaced the analog board, nibp-pcb, and ibp board resolved the issued.Ur-3712 pcb, analog, bsm2304 1 ea l ur-3643 pcb, nibp/hall sensor, bsm2300 1 ea l ur-3681 ibp board 1 ea l 608237 battery, bsm2300 1 ea l 6111008134b rear enclosure, bsm-2350 1 ea l 6111008125b front enclosure, bsm-2350 1 ea l 6124026508a nihon kohden logo sht, 2351/54 1 ea l 6124040225 bsm-2354a model label 1 ea l 6123012721a power indication sheet 2351/54 1 ea l 6112014767c right side panel, bsm2354 1 ea l 6112016925a input panel, left, bsm-2354a 1 ea l we also recommended the following parts below needed to be replaced: battery; front and rear cover; left and right side cover; nihon kohden logo; and model label (bsm-2304a).Power indication tested and completed all steps in the maintenance check sheet per the service manual.The unit completed 3 days of extended testing and operates to manufacturer's specifications.Investigation result(s): the bsm-2000 series was discontinued on august 3, 2011 due to the introduction of the bsm-6000 series monitor (see attached).Root cause of the issue has been identified to be degradation/failing of device components due to age and use over time.The device was installed in 12/06/2003 with a warranty that extended to 12/06/2008.The issue(s) with the device was reported on (b)(6) 2018, about 9 years after the end of warranty date.Moreover, physical damage was noted during repair center's evaluation of the customer's defective unit.Over time age and use increases the likelihood of failing parts, especially if the user has mishandled or physically abused the device during usage.The service manual recommends regular maintenance/periodic inspection on the unit, which may detect degradation or loss of function of the unit.Review of the device history record (dhr) shows that the unit has no history of ncmr, refurbishing, or other suspected defects (see attached).Recurrence of the issue is unlikely as the device has been discontinued.There is no suspected adverse trend and there is no indication of design deficiency.Investigation by qa has been completed as the root cause has been identified and investigational information within the record documents that the issue was resolved through servicing the unit.Corrected information: g4.Date received by manufacturer: should be 04/27/2018 not 05/25/2018 as listed on mdr initial report.

• Brand Name: BSM-2304A
• 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: 7546766
• MDR Text Key: 109361059
• Report Number: 8030229-2018-00176
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K011918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BSM-2304A
• Device Catalogue Number: BSM-2304A
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2019
• Distributor Facility Aware Date: 07/26/2019
• Device Age: 176 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2019
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1