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

Model Number ZM-531PA

Device Problems Device Displays Incorrect Message (2591); Output Problem (3005)

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

Event Date 10/13/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this transmitter was displaying bradycardia on a patient with a heart rate of 130.The customer would like to know why the unit was displaying bradycardia.The clinical specialist suggested relocating or replacing the leads would be the ideal troubleshooting step.The specialist stated that a heart rate of 130 should alarm for tachycardia.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: a2 - a6.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: no reply was received.B6 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: no reply was received.B7 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: no reply was received.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.

Event Description

The customer reported that this transmitter was displaying bradycardia on a patient with a heart rate of 130.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that this transmitter was displaying bradycardia on a patient with a heart rate of 130.The customer would like to know why the unit was displaying bradycardia.The clinical specialist suggested relocating or replacing the leads would be the ideal troubleshooting step.The specialist stated that a heart rate of 130 should alarm for tachycardia.There was no patient injury reported.Investigation summary: three attempts were made to reach the customer to ensure replacing and relocating the leads resolved the issue, but the customer was unresponsive.We were unable to confirm the reported issue.A definitive root cause could not be determined.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 10/18/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 10/20/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 10/24/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 10/18/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 10/20/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 10/24/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 10/18/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 10/20/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 10/24/2023 emailed the customer via microsoft outlook for patient information: no reply was received.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.Manufacturer references # 300345649 - 190139 follow up 001.

Event Description

The customer reported that this transmitter was displaying bradycardia on a patient with a heart rate of 130.There was no patient injury reported.

• 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: 18093789
• MDR Text Key: 327652435
• Report Number: 8030229-2023-03854
• 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: 01/29/2024

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: 10/13/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 01/26/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2017
• 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