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 Consequences Or Impact To Patient (2199)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that 2 different receivers on the multiple patient receiver (org) were getting signal drops.They tried multiple transmitters on different channels on the same receiver and no matter where the device was in the building, they were getting bad drop outs in signal (signal loss).The customer purchased one replacement nic card to see if that would resolve their issue, but we have not received confirmation on whether it resolved the 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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: device serial number, concomitant medical products, age of device, device manufacturing date.

Event Description

The biomedical engineer reported that 2 different receivers on the multiple patient receiver (org) were getting signal drops.They tried multiple transmitters on different channels on the same receiver and no matter where the device was in the building, they were getting bad drop outs in signal (signal loss).

Manufacturer Narrative

Details of the complaint: on (b)(6) 2019, customer at (b)(6) hospital reported signal drops on two different receivers.Customer did not know which org the receivers belonged to or if the receivers were from the same org.Monitoring was able to resume upon using a different transmitter.Service requested: troubleshooting/assistance.Service performed: information provided: zr-920p receiver, org-91xx 755.00.Investigation result : multiple attempts were made to obtain device sn however due to the lack of customer response, the information was not provided and investigation is limited.Customer currently has 4 org-9110a units registered, all of which are past warranty as of 09/26/18.No other ticket has been opened at ssm health (b)(6) hospital for product org-9110a.The org-9100 series multiple patient receiver can hold 8 receiver cards which would receive radio wave signals from up to 8 transmitters.It is unknown if the issue involved two receivers in the same org or one receiver in two different org units.Per org-9100a service manual rev h, periodic inspection is recommended at least once every year to detect degradation or loss of function.This includes checking the condition of the unit and receiver sensitivity.The receiver card zr-920a is a replaceable part.Troubleshooting and replacement of the receiver card is addressed in the org-9100a service manual.Customer's maintenance information is not available.The unit/receiver card was not returned and no nka evaluation was performed.From the available information, the root cause could not be determined.No adverse trend was found for issues with product org-9110a at (b)(6) hospital.Investigation conclusion: from the available information, the root cause could not be determined.No adverse trend was found for issues with product org-9110a at ssm health (b)(6) hospital.

Event Description

The biomedical engineer reported that 2 different receivers on the multiple patient receiver (org) were getting getting signal drops.They tried multiple transmitters on different channels on the same receiver and no matter where the device was in the building, they were getting bad drop outs in signal (signal loss).

• Brand Name: ORG-9110A
• Type of Device: MULTIPLE PATIENT RECEIVER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 9107633
• MDR Text Key: 193640580
• Report Number: 8030229-2019-00478
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• Combination Product (y/n): N
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2019
• Distributor Facility Aware Date: 11/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2019
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1