MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9700A; RECEIVER UNIT

Model Number ORG-9700A

Device Problems Computer Operating System Problem (2898); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported that there was telemetry dropout for two of the beds on the org.The rssi level when the device was turned off was reading at 6-7.The device was rebooted but the problem still remained.A loaner was sent to the customer.The customer reported that when the loaner was installed, two of the patient tiles that had patients being monitored changed as if they were available to admit and two other patient tile names were different.It is unknown how the tile changed occured.Customer was asked to verify the model of the org and cns software version as there was some miscommunication as to correct model and software version of both the cns and org.Customer verified that the defective model was the org-9700.Once verified the customer was asked to reboot the cns (central monitoring station) with the loaner org and track any signal loss and duplicate channel issues.Rebooting the cns did not resolve the issue.A spectrum analysis of the facility is being setup.The product involved in this event has not been returned to date to allow for an analysis to be performed.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if the product is returned for evaluation or new information is obtained.

Event Description

The customer reported that there was telemetry dropout for two of the beds on the org.The rssi level when the device was turned off was reading at 6-7.The device was rebooted but the problem still remained.A loaner was sent to the customer.

Manufacturer Narrative

Manufacturer narrative: the customer reported that there was telemetry dropout for two of the beds on the org.The rssi level when the device was turned off was reading at 6-7.The device was rebooted but the problem still remained.A loaner was sent to the customer.The customer reported that when the loaner was installed, two of the patient tiles that had patients being monitored changed as if they were available to admit and two other patient tile names were different.It is unknown how the tile changed occurred.Customer was asked to verify the model of the org and cns software version as there was some miscommunication as to correct model and software version of both the cns and org.Customer verified that the defective model was the org-9700.Once verified the customer was asked to reboot the cns (central monitoring station) with the loaner org and track any signal loss and duplicate channel issues.Rebooting the cns did not resolve the issue.A spectrum analysis of the facility is being setup.The product involved in this event has not been returned to date to allow for an analysis to be performed.The unit was evaluated and the problem was duplicated.Three of the 8 receivers are bad, unfortunately, the parts needed to repair are obsolete.Slot 3,4,&5 have an rssi level of zeros and ones.The org has been returned to the customer without repair as the customer wanted to get new org and keep the old parts until they are useless.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: ORG-9700A
• Type of Device: RECEIVER UNIT
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 486 nanokaichi; attn: shama mooman; gunma 370-2 343; JA 370-2343
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580 ; 2687488
• MDR Report Key: 5582418
• MDR Text Key: 43476503
• Report Number: 8030229-2016-00165
• Device Sequence Number: 1
• Product Code: DRG
• 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: 04/15/2016,03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORG-9700A
• Device Catalogue Number: MU-970RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2016
• Distributor Facility Aware Date: 03/16/2016
• Device Age: 96 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2016
• Initial Date Manufacturer Received: 04/15/2016
• Initial Date FDA Received: 04/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2008
• 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