MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-531PA; TRANSMITTER

Model Number ZM-531PA

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

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

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the telemetry transmitter displayed different numeric and waveform readings intermittently at the central nurses station (cns) than what was showing on the device itself.The issue was discovered while the transmitter was in use by a patient, but it was promptly replaced without any reports of harm or injury.The bme tested the transmitter on a simulator and found that it provided accurate readings.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 telemetry transmitter displayed different numeric and waveform readings intermittently at the central nurses station (cns) than what was showing on the device itself.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitter displayed different numeric and waveform readings intermittently at the central nurses station (cns) than what was showing on the device itself.The issue was discovered while the transmitter was in use by a patient, but it was promptly replaced without any reports of harm or injury.The bme tested the transmitter on a simulator and found that it provided accurate readings.Investigation summary: a definitive root cause could not be determined as the customer has been unresponsive, and we could not obtain further troubleshooting details.Since the device was not returned for evaluation, we could not duplicate the complaint.Based on the available details, possible causes include environmental interference or hardware failure.Electromagnetic interference from other devices may affect signal receiving.If there is another transmitter on-site using the same channel or nearby channel, the signals may become mixed.The operator's manual states to have the local administrator change the channel setting to troubleshoot the issue in this case.Hardware failure of the transmitter can occur through physical damage or fluid intrusion from user mishandling, power issues from short-circuits, which can occur through user error with battery insertion, or wear-and-tear, which depends on device age and frequency of use.Failure of the receiver card can occur through physical damage or fluid intrusion, power issues from site outages or surges affecting org components, or wear-and-tear.A review of the complaint device's serial number shows that the device is 2 years old and has no other complaints.A review of the customer's complaint history showed 1 previous similar complaint under ticket 111435 in which a transmitter had intermittent signal loss and irregular readings, and the cause was likely due to fluid intrusion as water damage was found on the device during evaluation.Nk will continue to monitor and trend similar complaints.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 06/08/2023 emailed the bme for all items under the no information list.No reply was received.Attempt # 2: 06/12/2023 emailed the bme for all items under the no information list.No reply was received.Attempt # 3: 06/15/2023 emailed the bme for all items under the no information list.No reply was received.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the transmitter: cns: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni org: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: na.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter displayed different numeric and waveform readings intermittently at the central nurses station (cns) than what was showing on the device itself.No patient harm was reported.

• Brand Name: ZM-531PA
• Type of Device: TRANSMITTER
• 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 ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17218519
• MDR Text Key: 318052202
• Report Number: 8030229-2023-03643
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115107
• UDI-Public: 04931921115107
• 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: 09/28/2023

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: ZM-531PA
• Device Catalogue Number: ZM-531PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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.; ORG.; ORG.