MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER

Model Number ZM-530PA

Device Problem Communication or Transmission Problem (2896)

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

Event Date 08/22/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the zm-530pa telemetry transmitter (tele) was monitoring a patient when the device stopped sending vitals to the central nurse's station (cns).There were no error messages displayed on the cns when this happened.Tech support (ts) asked them if they could try changing the transmitter the receiver card was looking at to see if the issue follows or if the issue is only with the one transmitter.The bme reported back stating that the issue follows this transmitter.They replaced it with another telemetry transmitter, but the issue persists.They returned the failed unit for a channel change to see if this would resolve their 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.The following fields are not applicable (na) to the mdr report: b2.D4 lot number & expiration.D6a - d6b.D7b.F1 - f14.G4 device bla number.G5.G7.H2.H7.H9.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.A2 - a6.B6 - b7.Attempt #1 08/24/2023 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the patient information as requested.Additional device information: d10: concomitant medical device: the following device(s) were being used in conjunction with the telemetry transmitter (tele).Central nurse's station.Model: cns-6801a.Sn: (b)(6).Device manufacturer date: 05/07/2018.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.Multiple patient receiver (org).Model: ni.Sn: ni.Device manufacturer date: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: not returned.

Event Description

The biomedical engineer (bme) reported that the zm-530pa telemetry transmitter (tele) was monitoring a patient when the device stopped sending vitals to the central nurse's station (cns).There were no error messages displayed on the cns when this happened.Tech support (ts) asked them if they could try changing the transmitter the receiver card was looking at to see if the issue follows or if the issue is only with the one transmitter.The bme reported back stating that the issue follows this transmitter.They replaced it with another telemetry transmitter, but the issue persists.They returned the failed unit for a channel change to see if this would resolve their issue.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter stopped sending vitals to the central nurse's station (cns).No error message was displayed at the cns.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitter stopped sending vitals to the central nurse's station (cns).No error message was displayed at the cns.The bme confirmed through testing a different transmitter that the issue was following this transmitter.No harm or injury was reported.Investigation summary: the reported device was sent in for an exchange but was not evaluated.The customer reported that the issue remained with the newly exchanged device, so they returned the exchange device for a channel change.The channel change service was documented under ticket (b)(4).The complaint device was received on 09/07/2023.Nihon kohden repair center (nk rc) serviced the unit on 09/13/2023 and changed the channel from 9374 to 9395.The unit was tested and operated to manufacturer's specifications.The device was returned to the customer on 09/14/2023.A review of the complaint device's serial number does not show recurrence of this issue or other complaints.A definitive root cause could not be determined from the troubleshooting, but based on the resolution, the possible cause is likely related to signal interference which can be caused by the use of transmitters on adjacent channels or environmental interference from other devices at the customer's site.The zm operator's manual includes instructions on channel management and how to reduce signal interference.A review of the customer's complaint history shows 1 similar complaint under ticket (b)(4) where the transmitter was not sending information to the cns.That issue was found to be due to water damage from user mishandling.A review of the customer's complaint history showed no trends for the reported issue.Nk will continue to monitor and trend similar complaints.Additional device information: d10: concomitant medical device: the following devices were used in conjunction with the telemetry transmitter: central nurse's station: model: cns-6801a.Sn: (b)(6).Device manufacturer date: 05/07/2018.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes.H10 additional manufacturer narrative.

• Brand Name: ZM-530PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• 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 ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17795826
• MDR Text Key: 324024633
• Report Number: 8030229-2023-03762
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043517
• 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: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-530PA
• Device Catalogue Number: ZM-530PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2022
• 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; CNS-6801A SN (B)(6); MULTIPLE PATIENT RECEIVER; MULTIPLE PATIENT RECEIVER (ORG)