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

Model Number ZM-531PA

Device Problem Unable to Obtain Readings (1516)

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

Event Date 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that they're not getting a numeric and the heart rate (hr) waveform is showing learning at the central nurse's station (cns).According to the customer, the telebox is showing the hr value, but on the cns they're not able to see this parameter.The customer tested the tele on a simulator with the same result.The customer changed the tele unit and no longer seeing the learning message.The customer is now seeing a numeric value for the patient.The customer will send in the unit to be repaired.There was no patient injury 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: the customer replied by stating; all information is unknown.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; all information is unknown.Attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; all information is unknown.Additional model information: concomitant medical product: the following device was used in conjunction with the zm transmitter.

Event Description

The customer reported that they're not getting a numeric and the heart rate (hr) waveform is showing learning at the central nurse's station (cns).According to the customer, the telebox is showing the hr value, but on the cns they're not able to see this parameter.There was no patient injury reported.

Event Description

The customer reported that they're not getting a numeric and the heart rate (hr) waveform is showing learning at the central nurse's station (cns).According to the customer, the tele box is showing the hr value, but on the cns they're not able to see this parameter.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that they're not getting a numeric and the heart rate (hr) waveform is showing learning at the central nurse's station (cns).According to the customer, the tele box is showing the hr value, but on the cns they're not able to see this parameter.The customer tested the tele on a simulator with the same result.The customer changed the tele unit and no longer seeing the learning message.The customer is now seeing a numeric value for the patient.The customer will send in the unit to be repaired.There was no patient injury reported.Investigation summary: the nihon kohden repair center received the zm transmitter and the reported issue could not be duplicated.They did not find any signs of physical damage or fluid intrusion.Numeric values and waveforms displayed correctly on the cns.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 06/26/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; all information is unknown.B6 attempt # 1: 06/26/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; all information is unknown.B7 attempt # 1: attempt # 1: 06/26/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; all information is unknown.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the zm transmitter: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.Manufacturer references (b)(4) follow up 001.

• 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: 17306854
• MDR Text Key: 319094132
• Report Number: 8030229-2023-03658
• 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: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• 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: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2021
• 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: CNS; CNS