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

Model Number ORG-9100A

Device Problem Application Program Problem (2880)

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

Event Date 02/24/2022

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bsm) reported that the multiple patient receiver (org) was not working after trying to setup hiq view feature.They tried to setup hiq view and rebooted the org and now it will not boot up.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.Additional device information: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.Telemetry transmitter(s) model: ni.Sn: ni.

Event Description

The biomedical engineer (bsm) reported that the multiple patient receiver (org) was not working after trying to setup hiq view feature.They tried to setup hiq view and rebooted the org and now it will not boot up.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bsm) reported that the multiple patient receiver (org) was not booting back up after a control reboot following an attempt to set up the hiq view feature.No patient harm was reported.Investigation summary: during the course of troubleshooting, nihon kohden technical support (nk ts) discovered that the customer was not using the appropriate software version of putty and did not have the appropriate connection cable to connect the org to their laptop.The customer was advised to address these issues before additional troubleshooting would be performed.Nk ts followed up with the customer for status updates, but they were left unanswered.The root cause is likely related to the use of incompatible software and/or use of an incompatible connecting cable.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 03/14/2022 emailed customer via microsoft outlook for all items under the no information section.The customer responded, but did not provide the requested information.Additional device information: d10: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.Telemetry transmitters: model: ni.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.

Event Description

The biomedical engineer (bsm) reported that the multiple patient receiver (org) was not booting back up after a control reboot following an attempt to set up the hiq view feature.No patient harm was reported.

• 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 ; 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: 13881202
• MDR Text Key: 289024199
• Report Number: 8030229-2022-02727
• 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: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• 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
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2010
• 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: TELEMETRY TRANSMITTER(S); TELEMETRY TRANSMITTERS