MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG; 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 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that there are multiple transmitters with intermittent signal loss while monitoring patients.The transmitter signals are being transmitted using the org-9110a multiple patient receivers.It is unclear what is causing their issues - environmental, device failure, network, etc.They do not want to troubleshoot and are requesting on-site servicing.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that there are multiple transmitters with intermittent signal loss while monitoring patients.The transmitter signals are being transmitted using the org-9110a multiple patient receivers.It is unclear what is causing their issues - environmental, device failure, network, etc.They do not want to troubleshoot and are requesting on-site servicing.

Manufacturer Narrative

Customer stated on (b)(6) 2019 that they were experiencing intermittent signal loss issue with random telemetry transmitters.These transmitters were monitored on pu-621ra s/n (b)(6).Eight or ten transmitters experience signal loss at a time.These transmitters were wirelessly connected to different org receivers.Customer and attempted to reboot the orgs but that didn't help the issue.The signal loss duration is between 10 to 20 seconds.Customer stated there was no construction nor cable tv that might interfere with the wireless signal.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: customer later reported that the amplifiers that were installed a couple of months ago were running at higher power than necessary.It is unknown as to how the amplifier power setting became higher than necessary.However, amplifier is part of the wireless infrastructure rather than patient monitoring device.Service history for this customer shows no additional intermittent signal loss issues.Update on 7/16/2019: as stated in the 5/9/2019 note, amplifiers are part of the antenna system.Due to information regarding the antenna system not being available, the cause of high amplifier setting is unknown.Corrected information: d1.Brand name.Incorrect brand name selected.D4.Model number.Incorrect model number selected.Catalog number.Incorrect model number selected.Unique identifier (udi) number.Incorrect udi number selected.F9.Approximate age of device.Incorrect age listed.No model/serial provided, unable to know age of device.G4.Date received by manufacturer: should be 04/08/2019 not 05/08/2019 as listed on mdr initial report.G5.Pma/510(k) number.Incorrect 510k number listed.H4.Device manufacturer date.No model/serial provided.Unable to determine device manufacturer date.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: d1.Brand name; d4.: model number; catalog number; serial; unique identifier (udi) number.F9.Approximate age of device.No model/serial provided so age of device is not known.G5.Pma/510(k) number.No model provided so 510k is not known.H4.Device manufacturer date.No model/serial provided.Unable to determine device manufacturer date.D11& c2 concomitant medical products: transmitter were monitored on the org.The cns was monitoring the org: cns; model: pu-621ra; serial: (b)(6); udi #: (b)(4); manufacturer date: 07/17/2012; age of device: 80 months.

Event Description

The customer reported that there are multiple transmitters with intermittent signal loss while monitoring patients.The transmitter signals are being transmitted using the org-9110a multiple patient receivers.It is unclear what is causing their issues - environmental, device failure, network, etc.They do not want to troubleshoot and are requesting on-site servicing.

• Brand Name: ORG
• 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: 8592020
• MDR Text Key: 144460894
• Report Number: 8030229-2019-00140
• 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: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• 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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2019
• Distributor Facility Aware Date: 07/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2019
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: TRANSMITTERSCNS