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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the multiple patient receiver (org) and multiple telemetry transmitters were in communication loss.The error lamp was lit on the org that was showing communication loss.Nihon kohden technical support (tech support) had them power cycle the org twice, but the error lamp was still on.Then they had them initialize the org but the error lamp is still on.The unit is being returned for evaluation.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: the following device(s) were being used in conjunction with the org, but model and serial number information was noted as no information (ni) for the telemetry transmitters, as attempts to obtain information were made but information was not provided.Central nurse's station model: cns-6201a sn: (b)(4).Telemetry transmitters model: ni sn: ni.

Event Description

The biomedical engineer reported that the multiple patient receiver (org) and multiple telemetry transmitters were in communication loss.The error lamp was lit on the org that was showing communication loss.Nihon kohden technical support (tech support) had them power cycle the org twice, but the error lamp was still on.Then they had them initialize the org but the error lamp is still on.The unit is being returned for evaluation.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the multiple patient receiver (org) and multiple telemetry transmitters were in comm loss.The error lamp on the org was lit.Nihon kohden technical support (nk ts) advised the customer to power cycle the org twice, but the error lamp was still lit.Then they asked them to initialize the org but there was still no change.The customer returned the unit for evaluation.No patient harm was reported.Service requested / performed: evaluation / repair.Investigation summary: the reported communication loss was not duplicated by nihon kohden repair center (nk rc) so a root cause cannot be determined.The customer reported a recurrence upon receiving the evaluated device.The customer reported that they would perform more testing but did not report any further issues with the device.The communication loss is likely resolved.The age of the org was 6 years at the time of the incident.As nk rc was not able to duplicate the issue, the comm loss is likely to be intermittent in nature.The error light is commonly caused by corrupt software.The customer has not reported any further issues or followed up.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) and multiple telemetry transmitters were in comm loss.The error lamp on the org was lit.Nihon kohden technical support (nk ts) advised the customer to power cycle the org twice, but the error lamp was still lit.Then they asked them to initialize the org but there was still no change.The customer returned the unit for evaluation.No patient harm 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: 11021316
• MDR Text Key: 234957244
• Report Number: 8030229-2020-00767
• 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: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2013
• 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
• Treatment: CNS-6201A SN (B)(6); CNS-6201A SN (B)(6); TELEMETRY TRANSMITTERS; TELEMETRY TRANSMITTERS