MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-930PA

Model Number ZM-930PA

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the transmitter gave irregular ecg readings.After researching the error code "low mv," nk ts found that it has to do with lead placement or defective leads or electrodes.The leads on the simulator may not be functioning correctly.The customer was advised to try changing them out, using proper lead placement to try and resolve the issue.Nk has not yet heard back regarding the results of the suggested troubleshooting tips.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.Additional device information: concomitant medical products: the following device was being used in conjunction with the transmitter: cns: no model or s/n was provided.

Event Description

The biomedical engineer (bme) reported that the transmitter gave irregular ecg readings.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the transmitter gave irregular ecg readings.After researching the error code "low mv," nk ts found that it had to do with lead placement or defective leads or electrodes.The leads on the simulator may not be functioning correctly.The customer was advised to try changing them out, using proper lead placement to try and resolve the issue.No patient harm or injury was reported.Investigation summary: the customer had used new leads and electrodes as well as redoing patient preparation, but the issue persisted.They replaced the complaint device with another transmitter and there were no issues with the new transmitter, suggesting that it is not likely a patient related issue or an environmental issue.The customer used a simulator on the transmitter and was getting a low mv error.The customer indicated that they have previously observed this low mv issue on a zm device that had fluid intrusion.The complaint device was not returned to be evaluated.The complaint device had been in service since 03/28/2008.A review of the history of the serial number identified no other issues reported on the device.Based on the available information, a definitive root cause could not be identified.Possible causes of the issue are physical damage on the device, fluid intrusion, and wear and tear of the components of the device.

Event Description

The biomedical engineer (bme) reported that the transmitter gave irregular ecg readings.

• Brand Name: ZM-930PA
• Type of Device: ZM-930PA
• 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: 10286558
• MDR Text Key: 200638706
• Report Number: 8030229-2020-00381
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946175
• 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: 07/16/2020,02/07/2023

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-930PA
• Device Catalogue Number: ZM-930PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2020
• Distributor Facility Aware Date: 06/16/2020
• Device Age: 149 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2020
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 02/02/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2007
• 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