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

Model Number ZM-531PA

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this unit is not reading for lead i, va, and vb when in auto mode.According to the customer, it does work when changed to 6 lead mode.There were no errors displayed.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: patient age/ dob, sex, weight, ethnicity & race.Attempt # 1: 03/09/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have any information, no patient was harmed.Relevant tests/laboratory data, other relevant history.Attempt # 1: 03/09/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have any information, no patient was harmed.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 unit is not reading for lead i, va, and vb when in auto mode.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the transmitter was not giving readings for lead i, va, and vb while in auto mode, but was working when they changed to the 6-lead mode.There were no error messages displayed.No harm or injury was reported.Investigation summary: the device was sent in for evaluation.Nihon kohden repair center (nk rc) was able to duplicate the reported issue.Nk rc found that the lcd screen was white due to an electronic failure of the main board.Nk rc did not find any physical damage or fluid intrusion.A definitive cause for the lack of ecg readings could not be determined but it is possible that the customer may have been using leads that were not compatible with the lead type setting on auto mode.According to the zm-531pa operator's manual, the user should set the lead type to "6 leads" if using din type leads with 6 electrodes.A definitive cause for the lack of error message/alarms when there were no ecg readings could not be determined but it is possible that this was due to failure of the device's internal hardware such as the main board.Internal hardware failure may be caused by wear-and-tear over time or extensive use, or power issues such as short-circuiting.Review of the device's serial number shows that the device is aged at over 8 years old and that it was repaired under a previous ticket (#45815) in which it was not showing readings for the va lead due to failure of its external parts, possibly linked to age of the device.Power issues resulting in hardware failure can occur through user error when incompatible batteries are inserted into the battery compartment or when batteries are not inserted into the compartment with the proper orientation.The zm-531pa operator's manual details proper installation of batteries as well as recommended types of batteries to use with the transmitter.No significant trend was identified.The nature of the complaint may be related to normal wear-and-tear and the age of the device.Nk will continue to monitor and trend similar complaints.The following fields contain no information (ni), as an attempt to obtain information was made, but not provided: a2 - a6 b6 b7 d10 attempt # 1: 03/09/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; "i do not have any information, no patient was harmed." 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 additional information: b4 date of this report d9 device available for evaluation? g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes h10 additional manufacturer narrative.

Event Description

The customer reported that the transmitter was not reading lead i, va, and vb while in auto mode.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: 16640236
• MDR Text Key: 312683033
• Report Number: 8030229-2023-03422
• 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: 06/23/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 07/23/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2014
• 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