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

Model Number ZM-531PA

Device Problem Output Problem (3005)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2022

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the ecg readings were not getting consistent readings.They have swapped the cables, but the readings are still not correct.They are expecting a normal waveform to appear showing 60 bpm because they have the telemetry transmitter hooked up to a patient simulator simulating that.The waveform is all over the place, especially for va.Not in patient use.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.Pma/510k: device bla number.

Event Description

The biomedical engineer (bme) reported that the ecg readings were not getting consistent readings.They have swapped the cables, but the readings are still not correct.They are expecting a normal waveform to appear showing 60 bpm because they have the telemetry transmitter hooked up to a patient simulator simulating that.The waveform is all over the place, especially for va.Not in patient use.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the zm transmitter was not giving consistent ecg readings.They tried swapping out the cables, but the issue persisted.This was occurring during testing on a simulator, so there was no patient involvement.Investigation summary: the device was sent in for an exchange and evaluation.During the evaluation of the returned device nihon kohden repair center (nk rc) observed physical damage on multiple parts of the transmitter.Physical damage is likely to occur as a result of mishandling or wear and tear.Mishandling of a device can be related to dropping the device, hard impacts, or improper use.Damage to the device can extend to internal components vital for operation.Wear and tear due to aging or frequency of use can gradually degrade components.Replacement of the damaged parts resolved the issue and the unit operated to manufacturer specifications.The device was installed in 03/2018 with no history of servicing.The root cause is likely related to wear and tear or mishandling.

Event Description

The biomedical engineer (bme) reported that the zm transmitter was not giving consistent ecg readings.They tried swapping out the cables, but the issue persisted.This was occurring during testing on a simulator, so there was no patient involvement.

• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 15397303
• MDR Text Key: 305813257
• Report Number: 8030229-2022-03068
• 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: 10/06/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 09/09/2022
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• 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