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

Model Number ZM-531PA

Device Problems Communication or Transmission Problem (2896); Output Problem (3005)

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

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the zm-531pa telemetry transmitter will intermittently drop the ecg at the central nurse's station (cns).The waveform will disappear, but no errors displayed, and no signal loss reported.The customer wants to do an exchange.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.

Event Description

The biomedical engineer reported that the zm-531pa telemetry transmitter will intermittently drop the ecg at the central nurse's station (cns).The waveform will disappear, but no errors displayed, and no signal loss reported.The customer wants to do an exchange.No patient harm reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the zm-531pa telemetry transmitter was intermittently dropping ecg readings at the central nurse's station (cns).The waveform would disappear, but no error messages were displayed, and no signal loss was reported.The transmitter was sent in for evaluation.No patient harm or injury was reported.Investigation summary: although there are risks posed by this issue, the issue can be easily detected.The reported issue would cause the desired parameter (in this case ecg) to be absent at the cns and monitoring clinicians would be able to easily detect this issue.Furthermore, there is no interruption in ecg monitoring on the zm devices.Nihon kohden repair center (nk rc) evaluated the complaint unit and was not able duplicate the reported issue.This suggests that the telemetry device is not defective.Based on the available information, a definitive root cause could not be identified.As there were no defects observed on the telemetry device, it is possible that the tile/bed of the cns where this telemetry device was being monitored did not have the appropriate settings.The parameter priority on ecg may have been set incorrectly, or ecg may not have been selected as a displayed parameter.As the issue is intermittent and was not observed during the evaluation, it could not be excluded that the customer's network environment may have contributed to the issue.The condition of the org for the telemetry device may have also contributed to the issue.

Event Description

The biomedical engineer (bme) reported that the zm-531pa telemetry transmitter was intermittently dropping ecg readings at the central nurse's station (cns).The waveform would disappear, but no error messages were displayed, and no signal loss was reported.No patient harm reported.

• Brand Name: ZM-531PA
• Type of Device: TELEMETRY 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12493579
• MDR Text Key: 272131379
• Report Number: 8030229-2021-01692
• 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: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2021
• 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
• Date Returned to Manufacturer: 09/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2011
• 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: CENTRAL NURSE'S STATION (CNS); CENTRAL NURSE'S STATION (CNS); MULTIPLE PATIENT RECEIVER (ORG); MULTIPLE PATIENT RECEIVER (ORG); CENTRAL NURSE'S STATION (CNS); MULTIPLE PATIENT RECEIVER (ORG)