MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A; MULTIPLE PATIENT RECEIVER

Model Number ORG-9100A

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 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the multiple patient receiver (orgs) are getting intermittent communication loss after they did an org upgrade to sw v04-51.The intermittent communication loss is on different orgs.This is happening on 4 different orgs and all at different times.It never happens all at once.This happens on 3 different central nurse's stations (cnss) which will show communication loss for the telemetry transmitters on that specific org.This happens intermittently on 3 different cnss across 4 different orgs.This may be a software version compatibility issue, the customer has informed me that they have a software upgrade for all of their cnss in the works and is already scheduled.This upgrade will not be able to take place until november.At this point the customer is going to down grade the org software version to the original version to take care of the software version compatibility issue, and then once the upgrade takes place they will upgrade the orgs as well.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.Concomitant medical device products: the following devices were being used in conjunction with the org.Central nurse's station: model: cns-6201a, sn: (b)(4).Central nurse's station: model: cns-6201a ,sn: (b)(4).Central nurse's station: model: cns-6201a, sn: (b)(4).Multiple patient receiver: model: org-9100a ,sn: (b)(4).Multiple patient receiver: model: org-9100a, sn: (b)(4).Multiple patient receiver: model: org-9100a ,sn: (b)(4).

Event Description

The biomedical engineer reported that the multiple patient receiver (orgs) are getting intermittent communication loss after they did an org upgrade to sw v04-51.The intermittent communication loss is on different orgs.This is happening on 4 different orgs and all at different times.It never happens all at once.This happens on 3 different central nurse's stations (cnss) which will show communication loss for the telemetry transmitters on that specific org.This happens intermittently on 3 different cnss across 4 different orgs.This may be a software version compatibility issue, the customer has informed me that they have a software upgrade for all of their cnss in the works and is already scheduled.This upgrade will not be able to take place until november.At this point the customer is going to down grade the org software version to the original version to take care of the software version compatibility issue, and then once the upgrade takes place they will upgrade the orgs as well.No patient harm reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer reported that the multiple patient receiver (orgs) are getting intermittent comm loss after an org software upgrade to version 04-51.This was occurring on four different orgs and at different times.The comm loss error was displaying on three different central nurse's stations (cnss) for the telemetry transmitters.This may be a software version compatibility issue.The customer was going to down grade the org software version to the original version to take care of the software version compatibility issue, and then once the pending upgrade takes place, they will upgrade the orgs as well.No patient harm was reported.Service requested / performed: troubleshooting.Investigation summary: the customer reported that intermittent communication loss was occurring after they had upgraded the software on their org's.The cnss that were communicating with the orgs were running on software version 01-06 which was not up to date.Nk tech support advised that the communication loss was most likely caused by the software update and that they should revert to the old org software versions and upgrade both the cns and org software together.No further issues were reported.As such, the root cause is most likely related to incompatible software.Additional information: b4 date of this report d8 was this device serviced by a third party? d9 device available for evaluation? 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.

Event Description

The biomedical engineer reported that the multiple patient receiver (orgs) are getting intermittent comm loss after an org software upgrade to version 04-51.This was occurring on four different orgs and at different times.The comm loss error was displaying on three different central nurse's stations (cnss) for the telemetry transmitters.

• Brand Name: ORG-9100A
• 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: 10452511
• MDR Text Key: 204866712
• Report Number: 8030229-2020-00472
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• 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: 08/25/2020,09/09/2022

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-9100A
• Device Catalogue Number: ORG-9100A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2020
• Distributor Facility Aware Date: 07/27/2020
• Device Age: 98 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2020
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 06/09/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2012
• 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-6201A SN (B)(6); CNS-6201A SN (B)(6); CNS-6201A SN (B)(6); CNS-6201A SN (B)(6); CNS-6201A SN (B)(6); CNS-6201A SN (B)(6); ORG-9100A SN (B)(6); ORG-9100A SN (B)(6); ORG-9100A SN (B)(6); ORG-9100A SN (B)(6); ORG-9100A SN (B)(6); ORG-9100A SN(B)(6)