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

Model Number ZM-531PA

Device Problems Signal Artifact/Noise (1036); No Device Output (1435); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the telemetry transmitter displayed a lot of artifact for the electrocardiogram (ecg) and would not produce a heart rate (hr) reading.When the bme tested it, they were able to duplicate the issue, and no error messages were displayed.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 contain no information (ni), as an attempt to obtain information was made, but not provided: a2 - a6.B6.B7.D10.Attempt # 1: (b)(6) 2023 emailed the bme for all items under the no information list: the bme responded, stating that the requested information was unknown.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.Returned to nihon kohden: na.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 showed a lot of artifact for the electrocardiogram (ecg) and would not produce a heart rate (hr) reading.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter showed a lot of artifact for the electrocardiogram (ecg) and would not produce a heart rate (hr) reading.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitter displayed a lot of artifact for the electrocardiogram (ecg) and would not produce a heart rate (hr) reading.When the bme tested it, they were able to duplicate the issue, and no error messages were displayed.No patient harm was reported.Investigation summary: nihon kohden (nk) received the complaint device on 10/17/2023.Nk repair center (rc) evaluated the device on 11/20/2023 and could not duplicate the complaint.No artifact was found during the evaluation.Nk rc found that the screen was discolored, there were signs of fluid intrusion, and that the battery ports were broken.A definitive root cause could not be determined since we could not duplicate the complaint; however, the malfunction may likely be related to the fluid intrusion and damage found on the battery ports, as these would affect the operation of electronic components.Fluid intrusion and physical damage to the device may occur through user mishandling.The zm operator's manual includes general handling instructions on battery insertion and how to properly secure the transmitter to the patient's clothing or bedside to prevent the device from dropping.A review of the complaint device's serial number does not show other complaints.A review of the customer's complaint history shows 2 similar complaints under tickets (b)(4), which were respectively found to be due to incorrect settings, fluid intrusion, and lack of maintenance.A review of the customer's complaint history for issues related to no ecg readings and noise/artifact did not reveal any trends for manufacturing defects.Nk will continue to monitor and trend similar complaints.Attempt # 1: 08/02/2023 emailed the bme for all items under the no information list: the bme responded, stating that the requested information was unknown.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; returned to nihon kohden: na.Org: model #: ni; serial #: ni; device manufacturer data: ni; unique identifier (udi) #: ni; returned to nihon kohden: na.

• 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: 17634709
• MDR Text Key: 322094907
• Report Number: 8030229-2023-03736
• 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: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2021
• 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.
• Patient Sex: Transgender