MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER

Model Number ZM-530PA

Device Problem Patient Data Problem (3197)

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

Event Date 03/06/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter was reading out of calibration on a few patients and was showing inaccurate readings.The bme reported there was no error messages when this occurred.Unit was taken out of use so no harm occurred, staff just checked spo2 with another device.Bme did some troubleshooting and during testing found: simulated 85% reads 80%, simulated 95% reads 100%, simulated 85% again, this time reads 98%.The bme tried different cable/probes, very erratic.Nihon kohden technical support sent the bme a warranty replacement.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the telemetry transmitter was reading out of calibration on a few patients and was showing inaccurate readings.The bme reported there was no error messages when this occurred.Unit was taken out of use so no harm occurred, staff just checked spo2 with another device.Bme did some troubleshooting and during testing found: simulated 85% reads 80%, simulated 95% reads 100%, simulated 85% again, this time reads 98%.The bme tried different cable/probes, very erratic.Nihon kohden technical support sent the bme a warranty replacement.No patient harm was 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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: reply was received from the customer who stated " i do not have any of that information.It was not that serious of anissue that we recorded any of that information.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter was reading out of calibration on a few patients and was showing inaccurate readings.The bme reported there was no error messages when this occurred.Unit was taken out of use so no harm occurred, staff just checked spo2 with another device.Bme did some troubleshooting and during testing found: simulated 85% reads 80%, simulated 95% reads 100%, simulated 85% again, this time reads 98%.The bme tried different cable/probes, very erratic.Nihon kohden technical support sent the bme a warranty replacement.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitter was reading out of calibration on a few patients and was showing inaccurate readings.The bme reported there was no error messages when this occurred.Unit was taken out of use so no harm occurred, staff just checked spo2 with another device.Bme did some troubleshooting and during testing found: simulated 85% reads 80%, simulated 95% reads 100%, simulated 85% again, this time reads 98%.The bme tried different cable/probes, very erratic.Nihon kohden technical support sent the bme a warranty replacement.No patient harm was reported.Service requested / performed: evaluation of the returned device was not able to confirm or duplicate the reported issue of inaccurate spo2 readings since there was fluid inside of the device which resulted in the unit being scrapped.Investigation summary: evaluation of the returned device was not able to confirm or duplicate the reported issue of inaccurate spo2 readings.There was fluid intrusion observed which resulted in the unit being scrapped.Though the reported issue was not duplicated, the fluid intrusion may have caused damage to internal circuit boards and resulted in hardware failure and may have caused intermittent inaccurate values.Root cause is likely fluid intrusion.Zm transmitters are not waterproof devices.

• Brand Name: ZM-530PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• 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: 16651229
• MDR Text Key: 312506081
• Report Number: 8030229-2023-03440
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• 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: 06/05/2023

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-530PA
• Device Catalogue Number: ZM-530PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/30/2023
• Supplement Dates Manufacturer Received: 05/23/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2020
• 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