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

Model Number ORG-9110A

Device Problem Communication or Transmission Problem (2896)

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

Event Date 07/08/2022

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the multiple patient receiver (org) will get intermittent signal loss every minute for about 15-20 seconds.This will affect a different receiver each time.They moved in another org and that one worked without issue.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.Attempt #1 07/15/2022 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the patient information as requested.Additional device information: concomitant medical device: the following device(s) were being used in conjunction with the org, but model and serial number information was noted as no information (ni), as attempts to obtain information were made but information was not provided.Central nurse's station.Model: cns-6801a.Sn: (b)(4).Telemetry transmitter(s).Model: zm-531pa.Sn: ni.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) will get intermittent signal loss every minute for about 15-20 seconds.This will affect a different receiver each time.They moved in another org and that one worked without issue.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) was getting intermittent signal loss every minute for about 15-20 seconds, affecting a different receiver each time.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the multiple patient receiver (org) was getting intermittent signal loss every minute for about 15-20 seconds, affecting a different receiver each time.No patient harm was reported.Investigation summary: real-time monitoring remains intact on bedside monitors (bsms) and can still alert caregivers to changes in vital signs or heart rhythm.An error message would appear to alert clinicians to the issue, at which time an alternate monitoring method could be prepared.As the device was not returned for evaluation, a root cause cannot be determined.The device was in the customer's possession as of 10/2013.Due to the age of the device being over 8 years old, the root cause for the signal loss is likely related to degradation of the device due to age.The reported device has no previous history of servicing.Further action is not warranted.The following fields contains no information (ni), as an attempt to obtain the information was made, but not provided.A2 - a6 b6 - b7 d10 attempt #1 07/15/2022 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the patient information as requested.Additional device information: d10: concomitant medical device: the following devices were being used in conjunction with the org: central nurse's station: model: cns-6801a sn: (b)(6) telemetry transmitters: model: zm-531pa sn: ni 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 h10 additional manufacturer narrative.

• 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 ; 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: 15176094
• MDR Text Key: 304138458
• Report Number: 8030229-2022-03020
• 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: 06/16/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 02/13/2023
• Supplement Dates FDA Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2013
• 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: CNS-6801A SN 01036; CNS-6801A, SN (B)(6); TRANSMITTER, (B)(6); ZM-531PA SN NI