MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BJ-900PA; ECG PATIENT CABLE

Model Number	BP-900PA
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer informed the nk employee that the 12-lead ecg sets they have were failing.They have had to order several replacement cables due to cable failure, specifically, the v6 lead has stopped working on all of their cables.The nk employee spot checked a couple and noted that there was no v6 waveform on any of the ones reviewed.In addition, the customer has had several fails completely, and one where only v1 works.No patient harm was reported.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.There was no lot # labeled on the ecg cables.
Event or Problem Description
The customer informed the nk employee that the 12-lead ecg sets they have in were failing.They have had to order several replacement cables due to cable failure, specifically, the v6 lead has stopped working on all of their cables.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the customer informed the nk employee that the 12-lead ecg sets they have were failing.They have had to order several replacement cables due to cable failure, specifically, the v6 lead has stopped working on all of their cables.The nk employee spot checked a couple and noted that there was no v6 waveform on any of the ones reviewed.In addition, the customer has had several fail completely, and one where only v1 works.No patient harm was reported.There was no lot # labeled on the ecg cables.Therefore, the following field was left blank: h4 device manufacturing date investigation summary: based on the information available, a definitive root cause cannot be established.The most probable explanation is disconnection of internal components from mechanical stress.Pulling the cable/cord with excessive force or from an improper angle results in internal degradation and may cause loss of function.A review of the customer's complaint history reveals one additional complaint, ticket (b)(4), of an out-of-box bj-900pa failure (obf).From the customer's report, the obf cable exhibited no function compared to the current complaint's pattern of loss of v6.Therefore, the root causes are unlikely to be related.Nihon kohden will continue to trend and monitor.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H11 additional manufacturer narrative.
Event or Problem Description
The customer informed the nk employee that the 12-lead ecg sets they have in were failing.They have had to order several replacement cables due to cable failure, specifically, the v6 lead has stopped working on all of their cables.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the customer informed the nk employee that the 12-lead ecg sets they have were failing.They have had to order several replacement cables due to cable failure, specifically, the v6 lead has stopped working on all of their cables.The nk employee spot checked a couple and noted that there was no v6 waveform on any of the ones reviewed.In addition, the customer has had several fail completely, and one where only v1 works.No patient harm was reported.There was no lot # labeled on the ecg cables.Therefore, the following field was left blank: h4 device manufacturing date investigation summary: based on the information available, a definitive root cause cannot be established.The most probable explanation is disconnection of internal components from mechanical stress.Pulling the cable/cord with excessive force or from an improper angle results in internal degradation and may cause loss of function.A review of the customer's complaint history reveals one additional complaint, ticket 233778, of an out-of-box bj-900pa failure (obf).From the customer's report, the obf cable exhibited no function compared to the current complaint's pattern of loss of v6.Therefore, the root causes are unlikely to be related.Nihon kohden will continue to trend and monitor.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h11 additional manufacturer narrative.Corrected information: h11: the wrong ticket # was referenced in the investigation summary.It originally said, "ticket (b)(4), of an out-of-box bj-900pa failure (obf)." it was corrected to say, "ticket (b)(4), of an out-of-box bj-900pa failure (obf).".
Event or Problem Description
The customer informed the nk employee that the 12-lead ecg sets they have in were failing.They have had to order several replacement cables due to cable failure, specifically, the v6 lead has stopped working on all of their cables.No patient harm was reported.

• Brand Name: BJ-900PA
• Common Device Name: ECG PATIENT CABLE
• 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 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 22205936
• Report Number: 8030229-2025-05021
• Device Sequence Number: 6682588
• Product Code: MHX
• UDI-Device Identifier: 04931921859711
• UDI-Public: (01)04931921859711
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K882254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2025

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
• Operator of Device: Health Professional
• Device Model Number: BP-900PA
• Device Catalogue Number: BP-900PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 09/04/2025; 09/04/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 09/11/2025; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.; NA.
• Patient Sex: Unknown