MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-541PA; TRANSMITTER

Model Number	ZM-541PA
Medical Device Problem Codes	Power Problem (3010); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that this transmitter is not working properly.According to the customer, the unit will almost shut off on its own sometimes even with new batteries.There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported that this transmitter is not working properly.According to the customer, the unit will almost shut off on its own sometimes even with new batteries.The display will go blank and when that happens, the central nurse's station (cns) loses connection with the device.The customer changed out the unit to resolve the issue.The customer will send in the unit to be exchanged.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 the information were made, but not provided: additional model information: d10 concomitant medical device: the following device was used in conjunction with the zm transmitter: rns: model #: ni.Serial #: ni.Device manufacturer date: ni.Unique identifier (udi) #: ni.Returned to nihon kohden.No.D10 attempt # 1: 05/08/2024 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 05/16/2024 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 3 05/22/2024 emailed the customer via microsoft outlook for device information: no reply was received.
Additional Manufacturer Narrative
Details of complaint: the customer reported that this transmitter is not working properly.According to the customer, the unit will almost shut off on its own sometimes even with new batteries.The display will go blank and when that happens, the central nurse's station (cns) loses connection with the device.The customer changed out the unit to resolve the issue.The customer will send in the unit to be exchanged.There was no patient injury reported.Investigation summary: the reported issue could not be duplicated or confirmed.A definitive root cause could not be determined.But based on the findings from repair center, the unit powered on with new batteries and connected to the cns.There was a dent in the middle battery contact.There were signs of exposure to fluid found around the unit and the rear case, as well as on the nibp board.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: additional model information: d10 concomitant medical device: the following device was used in conjunction with the zm transmitter: rns: model #: ni.Serial #: ni.Device manufacturer date: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: no.D10 attempt # 1: (b)(6) 2024 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: (b)(6) 2024 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 3 (b)(6) 2024 emailed the customer via microsoft outlook for device information: no reply was received.Corrected information: d4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the production identifier (pi) information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a.
Event or Problem Description
The customer reported that this transmitter is not working properly.According to the customer, the unit will almost shut off on its own sometimes even with new batteries.There was no patient injury reported.

• Brand Name: ZM-541PA
• Common Device Name: 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: 19377169
• Report Number: 8030229-2024-04288
• Device Sequence Number: 7529095
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: (01)04931921106617(21)3200
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K043517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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
• Operator of Device: Health Professional
• Device Model Number: ZM-541PA
• Device Catalogue Number: ZM-541PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CNS; CNS
• Patient Sex: Unknown