MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER

Model Number ORG-9110A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the multiple patient receivers (orgs) were displaying sawtooth waveform intermittently.(b)(4) ts is currently working to resolve the issue and advised that it could be an environmental issue.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 when additional information becomes available.

Event Description

The biomedical engineer (bme) reported that the multiple patient receivers (orgs) were displaying sawtooth waveform intermittently.(b)(4) ts is currently working to resolve the issue and advised that it could be an environmental issue.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the multiple patient receivers (orgs) were displaying sawtooth waveform intermittently.Nk ts is currently working to resolve the issue and advised that it could be an environmental issue.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the multiple patient receivers (orgs) were displaying sawtooth waveform intermittently.Nihon kohden technical support (nk ts) was working to resolve the issue and advised that it could be an environmental issue.No patient harm was reported.Investigation summary: nihon kohden technical support (nkts) asked the customer to provide information regarding the error messages present during the event.The customer stated they would collect the data and forward it to nk ts.Follow-ups to the customer resulted in no response.The root cause is undetermined due to the lack of information from the customer.The most likely cause was the facility's network environment.

• Brand Name: ORG-9110A
• Type of Device: 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: 10305707
• MDR Text Key: 199888946
• Report Number: 8030229-2020-00398
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• 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: 07/21/2020,02/01/2023

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-9110A
• Device Catalogue Number: ORG-9110A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2020
• Distributor Facility Aware Date: 06/26/2020
• Device Age: 94 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2020
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2012
• 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