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 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that there was intermittent signal loss being displayed on the central nurse's station (cns).It will drop into a small bout of "signal loss" roughly every 10 minutes, or it will go into a longer period of signal loss for up to 3 minutes.The bed tile will show "cannot analyze" on the cns screen, then the data goes away in full disclosure, and the event list shows "signal loss" for that period of missing data.No sawtooth waves in full disclosure or on the screen.The tile will show as completely blank on the cns screen.The cns will show a yellow signal loss alarm during these periods in the corresponding tile.The org multiple patient receiver was returned for evaluation.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: the following devices were being used in conjunction with the org.The serial numbers for the telemetry transmitters were not provided and therefore listed as no information (ni).Central nurse's station: model: cns-6801a, sn: (b)(4).Telemetry transmitter: model: zm-531pa, sn: ni.

Event Description

The biomedical engineer reported that there was intermittent signal loss being displayed on the central nurse's station (cns).It will drop into a small bout of "signal loss" roughly every 10 minutes, or it will go into a longer period of signal loss for up to 3 minutes.The bed tile will show "cannot analyze" on the cns screen, then the data goes away in full disclosure, and the event list shows "signal loss" for that period of missing data.No sawtooth waves in full disclosure or on the screen.The tile will show as completely blank on the cns screen.The cns will show a yellow signal loss alarm during these periods in the corresponding tile.The org multiple patient receiver was returned for evaluation.No patient harm reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer reported that there was intermittent signal loss displayed at the central nurse's station (cns).It would drop into a small bout of "signal loss" roughly every 10 minutes, or it would go into a longer period of signal loss for up to 3 minutes.The bed tile would show "cannot analyze" on the cns screen, then the data would disappear in full disclosure, and the event list showed "signal loss" for that period of missing data.The cns displayed a yellow signal loss alarm during these periods in the corresponding tile.The org multiple patient receiver was returned for evaluation.No patient harm reported.Service requested / performed: evaluation / repair.Investigation summary: the org in question was returned and evaluated by nihon kohden repair center (nk rc).The issue of intermittent signal loss was not duplicated after 24 hours of extended testing.The issue is unlikely to be the result of a device malfunction.Signal loss indicates that the org is unable to communicate with the nk cnss and rnss.Possible root causes include ethernet cable failure due to physical damage or issues with the customer's network.Ticket 92328 was opened to report subsequent events of communication loss and nk rc could not duplicate the issue.The software of the org was upgraded, and the unit was returned to the customer.It is likely that the new software update was able to address and issue with version 04-31, which may have been contributing to the signal loss.As the returned device was found to be in good working condition by nk repair center, it is likely that version 04-31 was the sole cause but issues with the customer's network environment could also have been a contributing factor.As the device was found to be in good working condition in two product evaluations, a capa is not warranted.

Event Description

The biomedical engineer reported that there was intermittent signal loss displayed at the central nurse's station (cns).It would drop into a small bout of "signal loss" roughly every 10 minutes, or it would go into a longer period of signal loss for up to 3 minutes.The bed tile would show "cannot analyze" on the cns screen, then the data would disappear in full disclosure, and the event list showed "signal loss" for that period of missing data.The cns displayed a yellow signal loss alarm during these periods in the corresponding tile.The org multiple patient receiver was returned for evaluation.No patient harm reported.

• 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: 10463501
• MDR Text Key: 205290960
• Report Number: 8030229-2020-00476
• 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: 08/27/2020,06/20/2022

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
• Date Returned to Manufacturer: 08/11/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2020
• Distributor Facility Aware Date: 07/28/2020
• Device Age: 40 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2020
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2017
• 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: CNS-6801A SN (B)(6); CNS-6801A SN (B)(6); ZM-531PA NO SNS; ZM-531PA NO SNS