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

Model Number ZM-531PA

Device Problems Communication or Transmission Problem (2896); Output Problem (3005)

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

Event Date 02/09/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter was not seen at the central nurse's station (cns) and no error messages.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the telemetry transmitter was not seen at the central nurse's station (cns) and no error messages.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 contains no information (ni), as attempts to obtain information were made, but the information was not provided: patient age, sex, weight ethnicity, race, relevant test/ laboratory data or relevant history& concomitant medical device(s).Attempt #1.02/13/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2.02/28/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3.03/02/2023 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the patient and additional device information as requested.Multiple patient receiver.Model: ni.Sn: ni.Central nurse's station.Model: ni.Sn: ni.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter was not visible at the central nurse's station (cns).There were no error messages.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitter was not visible at the central nurse's station (cns).There were no error messages.No patient harm was reported.Investigation summary: the customer indicated they could not acquire signals at the cns and that there was no error message.The complaint device was returned for an exchange, but not evaluated by nihon kohden.The root cause of the issue could not be identified.The zm transmitter may not be seen at the cns if the zm device is not a monitored device at the cns.The issue could also occur if the zm device has been discharged / removed from the cns.Users may also not see the zm device if it is an overview bed on the cns.The zm device would not be on the all beds screen but it would be on the overview bed window.A review of the history of the serial number identified no other complaints against the device.A definitive root cause could not be identified.Without a definitive root cause, countermeasures to prevent recurrence could not be identified.Furthermore, there was no significant trend regarding the issue.No corrective actions would be performed at this time.Nk will continue to trend and monitor the reported issue.The following fields contains no information (ni), as attempts to obtain information were made, but not provided.Attempt #1: 02/13/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: 02/28/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: 03/02/2023 emailed customer via microsoft outlook for all items under the no information section.The customer responded with complaint details, but did not provide the patient and additional device information as requested.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the zm transmitter: multiple patient receiver.Model: ni.Sn: ni.Central nurse's station: model: ni.Sn: ni.

• 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: 16525646
• MDR Text Key: 311571084
• Report Number: 8030229-2023-03415
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• 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
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2021
• 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: CENTRAL NURSE'S STATION; CENTRAL NURSE'S STATION; MULTIPLE PATIENT RECEIVER; MULTIPLE PATIENT RECEIVER