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

Model Number ORG-9100A

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the org multiple patient receiver is having issues and causing intermittent signal loss for multiple transmitters.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 if additional information becomes available.

Event Description

The customer reported that the org multiple patient receiver is having issues and causing intermittent signal loss for multiple transmitters.No patient harm was reported.

Manufacturer Narrative

Details of the complaint: customer reported that their org was having issues with signal loss.Signal loss was initially occurring in one room, but now intermittent signal loss was occurring in multiple rooms all tied to the org.The customer had tried power cycling the device and checking the rssi values multiple times but the issue persisted.Service requested: repair/loaner.Service performed: repair/loaner the unit was cleaned and decontaminated.The model, serial number, and all labels were verified.The reported problem of "the org-9100a sn-(b)(6) was having an issue "signal loss" was not duplicated.The root cause of the problem is "the org-9100a sn-(b)(6) was having an issue "signal loss." we setup, connected an org, and monitored all 8 receivers thru cns.We setup, admitted all 8 receivers and they all communicated with the transmitter and did not find any issue.The unit was tested per the operator's/service manual and the results were recorded on the attached maintenance check sheet.The unit completed 24 hours of extended testing and operates to the manufacturer's specifications.Investigation results: the root cause of the issue could not be determined at this time due to being unable to duplicate the reported issue.Old age and use over time can contribute to the degradation and failing of parts.The unit was installed in 2009 and at the time of the reported issue, the device was 5 years past the warranty end date.The device service record shows that the unit has had previous notifications created for signal issues and one of them was remedied by replacing a receiver card.Trending analysis also shows that there is no adverse trend suspected or indication of design deficiency.Possible causes for the issue include environmental factors and/or bad receiver card(s).This complaint record can be qa closed as investigational information within the record indicates that the device was performing as the manufacturer intended.Device service history for similar instances: notification 300062183 - troubleshooted notification 300157090 - had receiver card replaced.Trending for similar tickets query "org-9100a intermittent signal loss" for 2018 tickets and later: 56467 - root cause of the issue could not be identified.Service history indicates that environmental interference is a common cause.Device 4 years old 55527 - root cause unidentified at this time.Currently pending repair center evaluation.Device 7 years old.44712 - issue could not be duplicated by the repair center.Device was performing as intended.Device 2 years old.33662 - root cause of the issue could not be identified.Investigation in progress still.Device 9.5 years old.22675 - the issue could not be duplicated, but repair center found that 2 of the 4 receiver cards had low rssi levels.All 4 receiver cards replaced to resolve issue.Device 5 years old.Review of tickets opened at customer facility for "signal" issues found the following: 31671/300128485 reported 06/15/18 for org-9100a sn: (b)(6).68131/300181574 reported 09/12/19 for pu-621ra sn:(b)(6) connected to org-9100a sn: (b)(6)).Ongoing signal loss in room 160 whenever a patient enters the bathroom.A stairwell is noted to be between the closest antenna and room.Customer's signal loss issues are not isolated to the current org in question.Evaluation of customer's org (sn: (b)(6)) at nka found unit to be operating within specifications.Additionally, per nkc dhr (attached), the unit has had no history of ncmr, deviation, or capa during manufacturing of the device.The device has not been refurbished and there were no discrepancies or unusual findings before device release that might relate to the reported issue.Customer continues to experience signal loss with the returned org (sn: (b)(6)) at one particular location.Possible contributing factors include those which cannot be troubleshot within nka test environment, such as issue with the infrastructure, antenna system, or electromagnetic interference at the facility.Customer has requested on site support for further troubleshooting in ticket 68131.From the information currently available, the root cause could not be determined however no deficiency of the org is suspected.Corrected information: f9.Approximate age of device: incorrectly calcuated.G4.Date received by manufacturer: should be 03/19/2019 not 04/18/2019 as listed on mdr initial report.

Event Description

The customer reported that the org multiple patient receiver is having issues and causing intermittent signal loss for multiple transmitters.No patient harm was reported.

• Brand Name: ORG-9100A
• 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: 8529992
• MDR Text Key: 142489548
• Report Number: 8030229-2019-00106
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• 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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2019
• Distributor Facility Aware Date: 10/22/2019
• Device Age: 126 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2019
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.