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

Model Number ZM-531PA

Device Problems Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 10/13/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the transmitter is showing a lot of noise in the ecg wave forms while monitoring on a patient.The bme swapped out the transmitter with another transmitter and that one worked.No patient injury reported.The bme requested a warranty exchange and will return this unit to nihon kohden.

Manufacturer Narrative

The biomedical engineer (bme) reported that the transmitter is showing a lot of noise in the ecg wave forms while monitoring on a patient.The bme swapped out the transmitter with another transmitter and that one worked.No patient injury reported.The bme requested a warranty exchange and will return this unit to nihon kohden.Nihon kohden sent out a warranty exchange unit and are awating the return of this device.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 attempts to obtain information were made, but not provided: a2 - a6, b6, b7, d10.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply has been received.

Manufacturer Narrative

The biomedical engineer (bme) reported that the transmitter is showing a lot of noise in the ecg wave forms while monitoring on a patient.The bme swapped out the transmitter with another transmitter and that one worked.No patient injury reported.The bme requested a warranty exchange and will return this unit to nihon kohden.Nihon kohden sent out a warranty exchange unit and are awating the return of this device.Evaluation of returned unit: the returned unit was decontaminated and physical damage found near the rear of the battery case cover and vco box damaged.When tested the unit did not show any noise in the ecg waveforms on the cns or on the unit, however intermittent signal loss was found.Device was scrapped since there was substantial damage to it.Investigation summary: upon further inspection from the repair center, we were unable to duplicate the reported issue.As such a definitive root cause could not be determined.The unit was tested with new batteries with ecg noise issues.They discovered the unit had intermittent signal loss, physical damage to the rear battery case cover and the vco box was damaged.The most probable cause of noise could be contributed to the physical damage on the unit or interferences within the hospital that was causing noise.Device history: a serial number review of the reported device ((b)(6) serial number (b)(6)) does not reveal additional related complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.Nk ill continue to monitor and trend similar complaints.

Event Description

The biomedical engineer (bme) reported that the transmitter is showing a lot of noise in the ecg wave forms while monitoring on a patient.The bme swapped out the transmitter with another transmitter and that one worked.No patient injury reported.The bme requested a warranty exchange and will return this unit to nihon kohden.

• 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: 18088763
• MDR Text Key: 328498916
• Report Number: 8030229-2023-03860
• Device Sequence Number: 1
• Product Code: DRT
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• 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: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2017
• 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