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

Model Number ZM-531PA

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460); Output Problem (3005)

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

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) stated that they are getting low spo2 readings across multiple telemetry transmitters.They stated that they are using the tl-271t3 spo2 cables and getting low sat readings.They measured them against a bedside monitor and get different readings than when plugged into the telemetry transmitters.This is occurring on are zm-530pa and zm-531pa telemetry transmitter models.They are not sure if this is a cable issue or user issue.They were going to check to see if these cables are coming from a single lot number to determine if they have a bad batch of spo2 cables or not.We have contacted the customer for the lot number of the spo2 leads and other information, but the customer has been unresponsive.No patient harm reported.Additional model information: concomitant medical device: the following devices were being used in conjunction with the telemetry transmitters, but the serial number and lot number information was not provided and was noted as missing information (mi).Spo2 probe: model: tl-271t3, lot: mi; telemetry transmitter: model: zm-530pa, sn: (b)(4).

Event Description

The biomedical engineer (bme) stated that they are getting low spo2 readings across multiple telemetry transmitters.They stated that they are using the tl-271t3 spo2 cables and getting low sat readings.They measured them against a bedside monitor and get different readings than when plugged into the telemetry transmitters.This is occurring on are zm-530pa and zm-531pa telemetry transmitter models.They are not sure if this is a cable issue or user issue.They were going to check to see if these cables are coming from a single lot number to determine if they have a bad batch of spo2 cables or not.We have contacted the customer for the lot number of the spo2 leads and other information, but the customer has been unresponsive.No patient harm reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) stated they were getting low spo2 readings across multiple telemetry transmitters.They were using tl-271t3 spo2 cables and getting low sat readings.They measured them against a bedside monitor (bsm) and got different readings than when plugged into the telemetry transmitters.No patient harm or injury was reported.Investigation summary: nihon kohden technical support (nk ts) requested the lot number(s) for the cables in use.Follow-up attempts to gather information of demographics for reporting have not received a response.After several attempts, the customer replied stating the issue was resolved.No further information was provided.With the available information a root cause cannot be determined.The most common cause for this issue is lead/probe placement or patient movement during a measurement.A review of the serial number history shows no recurrence of the reported issue.Spo2 cable/probe-sensor: as a cable is required to connect the probe to the spo2 module, failure of the cable is likely to contribute to spo2 issues.Improper connection by way of improper seating or connection port may also cause spo2 reading failures.Users should verify that all cable connections are secure before monitoring a patient.Use of unauthorized probes or cables is likely to lead to spo2 issues.Cables can become damaged because of mishandling or wear and tear.As this module is mobile, impacts from normal use may contribute to damage of the exterior closure and internals of the device.

Event Description

The biomedical engineer (bme) stated that they were getting low spo2 readings across multiple telemetry transmitters.They were using the tl-271t3 spo2 cables and getting low sat readings.They measured them against a bedside monitor (bsm) and got different readings than when plugged into the telemetry transmitters.No patient harm 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 ; 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: 10557545
• MDR Text Key: 242591648
• Report Number: 8030229-2020-00536
• 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: 03/02/2023

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: 08/19/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2014
• 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: SPO2 CABLES TL-271T3; TL-271T3; TRANSMITTERS ZM-530PA; ZM-530PA