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

Model Number ZM-531PA

Device Problem Communication or Transmission Problem (2896)

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

Event Date 12/28/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that 4 different transmitters in signal loss (comm loss).According to the customer, these are all zm-531pa units and they're working on getting the serial numbers.The receiver cards have been replaced by an nk team that was onsite; however, the issue remains.It is unknown whether the units were in patient use at the time.Nihon kohden continues to investigate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.

Event Description

The customer reported that 4 different transmitters in signal loss (comm loss).It is unknown whether the units were in patient use at the time.

Event Description

The customer reported that 4 different transmitters in signal loss (comm loss).It is unknown whether the units were in patient use at the time.

Manufacturer Narrative

Details of complaint: the customer reported that 4 different transmitters in signal loss (comm loss).According to the customer, these are all zm-531pa units and they're working on getting the serial numbers.The receiver cards have been replaced by an nk team that was onsite; however, the issue remains.It is unknown whether the units were in patient use at the time.Investigation summary: the customer reported signal loss occurring on one wing of their hospital.The customer replaced all of their receiver cards in the orgs and a few of their zms but the issue persisted.Nihon kohden (nk) tech support attempted to gather information surrounding the issue from the customer in order to find resolution, however, the customer was not responsive and did not provide answers for the questions.The root cause cannot be determined.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 date: ni unique identifier (udi) #: ni returned to nihon kohden: no.

• 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: 18564404
• MDR Text Key: 333539352
• Report Number: 8030229-2024-04047
• 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: 04/17/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2023
• 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.