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

Model Number	ORG-9100A
Medical Device Problem Codes	Failure to Power Up (1476); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that an nk tech was re-setting the org unit and when they went to turn it back on, it would not power up.The unit is being exchanged.There was no patient injury 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.Attempt # 1: 06/28/2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; the org went down with no harm to patients.
Event or Problem Description
The customer reported that an nk tech was re-setting the org unit and when they went to turn it back on, it would not power up.There was no patient injury reported.
Event or Problem Description
The customer reported that an nk tech was re-setting the org unit and when they went to turn it back on, it would not power up.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that an nk tech was re-setting the org unit and when they went to turn it back on, it would not power up.The unit is being exchanged.There was no patient injury reported.Investigation summary: based on the notes from on-site support, the root cause of the signal loss is a combination of improper set-up, device wear and tear, incorrect settings, and environmental factors.This incident is isolated to this customer.There is no evidence that the signal loss was occurring due to a malfunction of pu-681ra serial number (b)(6).Manufacturer references # (b)(4) follow up 001.

• Brand Name: ORG-9100A
• Common Device Name: MULTIPLE PATIENT RECEIVER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• 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
• MDR Report Key: 14986813
• Report Number: 8030229-2022-02954
• Device Sequence Number: 1562721
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K071058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2022

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
• Operator of Device: Health Professional
• Device Model Number: ORG-9100A
• Device Catalogue Number: ORG-9100A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown