MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER

Model Number ORG-9110A

Device Problem Communication or Transmission Problem (2896)

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

Event Date 04/28/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the multiple patient receiver (org) went into communication loss twice in two days.All receivers in the org seemed to be affected, but they have not had more than 2 - 3 patients on this org at any given time, and they did not provide any further information.They called in to see if there was anything they could do to prevent this.Rebooting the unit fixes the issue.Nihon kohden technical support suggested that they send the unit in for evaluation.They stated they will consider it and let us know.No patient harm 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.Additional device information: concomitant medical device information.Telemetry transmitter: model: zm-521pa, sn: (b)(4).

Event Description

The biomedical engineer reported that the multiple patient receiver (org) went into communication loss twice in two days.All receivers in the org seemed to be affected, but they have not had more than 2 - 3 patients on this org at any given time, and they did not provide any further information.They called in to see if there was anything they could do to prevent this.Rebooting the unit fixes the issue.Nihon kohden technical support suggested that they send the unit in for evaluation.They stated they will consider it and let us know.No patient harm reported.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) went into comm loss twice in two days.All receivers in the org seemed to be affected, but they have not had more than 2 - 3 patients on this org at any given time, and they did not provide any further information.They called to see if there was anything they could do to prevent this.Rebooting the unit fixed the issue.Nihon kohden technical support suggested that they send the unit in for evaluation.They stated they will consider it and let us know.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the multiple patient receiver (org) went into comm loss twice in two days.All receivers in the org seemed to be affected, but they have not had more than 2 - 3 patients on this org at any given time, and they did not provide any further information.They called to see if there was anything they could do to prevent this.Rebooting the unit fixed the issue.Nihon kohden technical support suggested that they send the unit in for evaluation.They stated they will consider it and let us know.No patient harm was reported.Service requested / performed: evaluation / repair.Investigation summary: this device was sent in for evaluation on a subsequent ticket, 81520 on 05/20/2020.Nihon kohden repair center (nk rc) was not able to duplicate the issue of communication loss on org-9110a sn: (b)(6) in ticket 81520.As such the root cause for the comm loss on this org cannot be determined.As the org was found to be in good working condition by nk rc, the cause of the comm loss is most likely related to the customer's network environment.Communication loss occurs when the org is not able to communicate with cn's or rns's on the customer network.Ethernet cable damage, defective customer network switches, and instability in the customer network are known causes of communication loss on the customer's side.As the cause of the issue cannot be confirmed and the unit was found to be in good working condition, a capa is not warranted.

• Brand Name: ORG-9110A
• Type of Device: MULTIPLE PATIENT RECEIVER
• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10093697
• MDR Text Key: 200649311
• Report Number: 8030229-2020-00282
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071058
• 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: 05/27/2020,06/27/2022

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: ORG-9110A
• Device Catalogue Number: ORG-9110A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/27/2020
• Distributor Facility Aware Date: 04/30/2020
• Device Age: 77 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2020
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 06/10/2022
• Supplement Dates FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2013
• 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: ZM-521PA SN (B)(6); ZM-521PA SN (B)(6)