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

Model Number ORG-9700A

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2022

Event Type  malfunction  

Event Description

The customer reported that hr numerics on the telemetry transmitter do not match was is displayed on the central nurse's station (cns).They put a simulator on the telemetry transmitter which displays 60 the entire time.However on the cns, it may display as 60, but then show 48 again.They tried another transmitter on this channel and the issue persisted.They moved to telemetry transmitter that was initialing having issues to another working channel, and it did not have issues.The issue is with one receiver card on the multiple patient receiver (org).No patient harm was reported.

Manufacturer Narrative

The customer reported that hr numerics on the telemetry transmitter do not match was is displayed on the central nurse's station (cns).They put a simulator on the telemetry transmitter which displays 60 the entire time.However on the cns, it may display as 60, but then show 48 again.They tried another transmitter on this channel and the issue persisted.They moved to telemetry transmitter that was initialing having issues to another working channel, and it did not have issues.The issue is with one receiver card on the multiple patient receiver (org).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.The following fields are not applicable (na) to the mdr report: outcomes attributed to adverse event; lot number & expiration; implant date and explant date; device bla number; if follow-up, what type; recall (if recall number is given) or correction/removal number (if given); correction/removal number.Attempt #1: 05/31/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: 06/13/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: 06/20/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device 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), as attempts to obtain information were made but information was not provided.Attempt #1: 05/31/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: 06/13/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: 06/20/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

Event Description

The customer reported that hr numerics on the telemetry transmitter do not match was is displayed on the central nurse's station (cns).They put a simulator on the telemetry transmitter which displays 60 the entire time.However on the cns, it may display as 60, but then show 48 again.They tried another transmitter on this channel and the issue persisted.They moved to telemetry transmitter that was initialing having issues to another working channel, and it did not have issues.The issue is with one receiver card on the multiple patient receiver (org).No patient harm was reported.

Manufacturer Narrative

Details of the complaint: the customer reported that hr numerics on the telemetry transmitter do not match was is displayed on the central nurse's station (cns).They put a simulator on the telemetry transmitter which displays 60 the entire time.However on the cns, it may display as 60, but then show 48 again.They tried another transmitter on this channel and the issue persisted.They moved to telemetry transmitter that was initialing having issues to another working channel, and it did not have issues.The issue is with one receiver card on the multiple patient receiver (org).No patient harm was reported.Investigation conclusion: the cause of the fluctuating heart rate on the cns was traced to a defective receiver card on an org-9700.As the org-9700 had topped being supported in 06/2016, it is likely that the receiver card became defective due to wear and tear and/or aging.The customer was sent the service manual so that it can be repaired by the customer.They were also advised that they could order a current org model.The root cause is likely related to aging and from normal use.

• Brand Name: ORG-9700A
• Type of Device: RECEIVER UNIT
• 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: 14794893
• MDR Text Key: 303294169
• Report Number: 8030229-2022-02920
• 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: 08/22/2022

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
• Device Operator: Health Professional
• Device Model Number: ORG-9700A
• Device Catalogue Number: MU-970RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/23/2022
• Supplement Dates Manufacturer Received: 08/19/2022
• Supplement Dates FDA Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2004
• 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: TELEMETRY TRANSMITTER; TELEMETRY TRANSMITTER