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

Model Number ORG-9110A

Device Problems Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535); Communication or Transmission Problem (2896); Output Problem (3005)

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

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their multiple patient receiver (org) is experiencing dropouts and showing artifact for several receiver cards.No harm or injury 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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: concomitant medical products.

Event Description

The customer reported that their multiple patient receiver (org) is experiencing dropouts and showing artifact for several receiver cards.No harm or injury was reported.

Manufacturer Narrative

Details of complaint: the customer reported that the multiple patient receiver (org) was experiencing signal dropouts and showing artifact for several receiver cards.No patient harm was reported.Investigation summary: the customer also stated there were artifacts on several receivers and they were requesting eight (8) receiver cards.Nihon kohden technical support (nk ts) requested additional information to provide the best possible support.However, the customer declined to provide the requested information.Nk ts initiated an exchange of the requested receiver cards.An evaluation of the receiver cards by nihon kohden repair center (nk rc) was performed.They were able to duplicate the reported issue as well as find that noise (artifact) for spo2 and respiration was present.With the available information, the root cause is due to the defective receiver cards.The defective receiver cards were scrapped by nk rc.A review of the serial number history for the org shows no recurrence of the reported issue.

Event Description

The customer reported that the multiple patient receiver (org) was experiencing signal dropouts and showing artifact for several receiver cards.No harm or injury was reported.

• 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: 10469266
• MDR Text Key: 204916140
• Report Number: 8030229-2020-00496
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/28/2020,03/03/2023

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: 08/28/2020
• Distributor Facility Aware Date: 08/03/2020
• Device Age: 93 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2020
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 03/01/2023
• Supplement Dates FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2012
• 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