MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION; BEDSIDE MONITOR

Device Problems Overheating of Device (1437); Failure to Power Up (1476); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the data acquisition unit for the bedside monitor system does not power on at all.They swapped out the cable on this unit, and it still did not power on.However, they stated when removing the original cable from the data box, that the cable and the inside connection smelled burnt.The device was not in patient use.Nihon kohden continues to investigate the reported event.Additional device information: concomitant medical device: the following device(s) were being used in conjunction with the bsm.Data acquisition unit: model: ja-694pa.(b)(4).Device manufacturer date: 04/22/2020.Approximate age of device: 11 months.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.

Event Description

The biomedical engineer reported that the data acquisition unit for the bedside monitor system does not power on at all.They swapped out the cable on this unit, and it still did not power on.However, they stated when removing the original cable from the data box, that the cable and the inside connection smelled burnt.The device was not in patient use.

Event Description

The biomedical engineer (bme) reported that the data acquisition unit for the bedside monitor would not power on.They swapped out the cable on the unit, but the issue persisted.When removing the original cable from the data box, the cable and the inside connector smelled like it had been burning.The device was not in patient use.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the data acquisition unit for the bedside monitor would not power on.They swapped out the cable on the unit, but the issue persisted.When removing the original cable from the data box, the cable and the inside connector smelled like it had been burning.The device was not in patient use.Investigation summary: the data acquisition unit was sent in for evaluation.During the evaluation of the returned device nihon kohden repair center (nk rc) was able to confirm the issue of the unit not powering on.Startup failure of a device is likely related to the failure of the hardware.The hardware failure may have resulted in the burning smell reported by the customer.Hardware failure could come as a result of physical damage, heat damage, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Heat damage could occur due to improper maintenance or device placement.Electrical damage could occur during a power outage or power surge.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: d1 brand name.D4 model number.Catalog number.Serial number.Udi number.G4 pma / 510k number.H4 device manufacture date.Attempt #1 03/29/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 03/30/2021 emailed customer via microsoft outlook for all items under the no information section.The customer responded that they would look into the matter but no information was provided.Attempt #3 04/12/2021 emailed customer via microsoft outlook for all items under the no information section.The customer responded, but did not provide the requested information.Additional device information: d10: concomitant medical device: the following device was being used in conjunction with the bsm and is the device that experienced the failure and which was sent in for evaluation: data acquisition unit: model: ja-694pa.Sn: (b)(6).Device manufacturer date: 04/22/2020.Approximate age of device: 11 months.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: 04/28/2021.Additional information: b4 date of this report.D9 device available for evaluation? d10 concomitant medical device.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes.H10 additional manufacturer narrative.

• Brand Name: NI
• Type of Device: BEDSIDE MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 11721485
• MDR Text Key: 249672108
• Report Number: 8030229-2021-00234
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: DATA ACQUISITION UNIT.; JA-694PA SN (B)(6).