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 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the multiple patient receiver (org) failed and was having signal loss when monitoring telemetry transmitters.Everything on the.20 segment of the network was affected and one whole side of telemetry transmitters and all cns and rnss.This started when the nihon kohden installer attempted to switch out a few switches in the 7th floor closet.And the customer believes that he just went in there and unplugged all of the cables at once out of the switch, and then didn't know what went where when it was time to put them all back.That installer left the system showing communication loss in several sectors, and then the 2nd install team that came in after him found the fiber cable was not plugged in completely and several cables in the wrong spot.They also found an org that had failed, but the installers did not replace it and just brought it back to their biomed shop.This signal loss and communication loss issue has not been resolved.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.Additional model information: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.

Event Description

The biomedical engineer reported that the multiple patient receiver (org) failed and was having signal loss when monitoring telemetry transmitters.

Manufacturer Narrative

Details of complaint: on 11/20/2019, it was reported that org device was showing communication loss on all telemetry beds.The error led would not go away after device was restarted.Org device was sent to nka for evaluation and repair.Nka repair center evaluated the device.No physical damages were noted.The reported issue of error led was observed.The following part needed replacement to resolve the issue: ur-3981 cpu board for org-9100 1 ea investigation conclusion: org device operator's manual recommends yearly inspection check to ensure that device is working as intended.There is no information when the last inspection check was done and whether any errors were noted.Ur-3981 cpu board is a replaceable component.The reported communication loss issue was caused cpu board failure, which in turn caused the org device to malfunction.There is not enough information to determine the root cause of the cpu board failure.Due to the low occurrence rate and moderate risks involved, further action is not warranted at this time.The following fields are not applicable (na) to the mdr report: d4: lot# & expiration date.Additional model information: d11 & c2: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.Additional information: b4 date of this report.D10 device available for evaluation.F6 date user facility/ importer became aware of the event.F7 type of report.F11 date report sent to fda.F13 date report sent to manufacturer.G4 date received by manufacturer.G7 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 (org) failed and was having signal loss when monitoring telemetry transmitters.

• 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: 9477846
• MDR Text Key: 200812101
• Report Number: 8030229-2019-00719
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2020
• Distributor Facility Aware Date: 04/12/2020
• Device Age: 51 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2020
• Date Manufacturer Received: 04/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1