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

Model Number ZM-531PA

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 04/20/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported, that when testing the transmitter.It sent different readings to the central nurses station (cns) than it was showing.The transmitter's readings were correct, but not on the cns.Not in patient use.

Manufacturer Narrative

Biomed reported, that when testing the transmitter.It sent different readings to the central nurses station (cns) than it was showing.The transmitter's readings were correct, but not on the cns.Biomed tested other devices with the cns, and it was just this device that had the issue.There were no signs of physical damage or fluid intrusion.Not in patient use.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.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the transmitter: attempt # 1: on (b)(6) 2023 emailed the customer for concomitant medical device information: no reply was received.Attempt # 2: on (b)(6) 2023 emailed the customer for concomitant medical device information: no reply was received.Attempt # 3: on (b)(6) 2023 emailed the customer for concomitant medical device information: no reply was received.

Event Description

The biomedical engineer (bme) reported that when testing the transmitter, the readings displayed on the central nurses station (cns) differed from the actual readings of the transmitter.Not in patient use.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that when testing the transmitter, the readings displayed on the central nurses station (cns) differed from the actual readings of the transmitter.The bme tested other devices and found them to be working correctly with the cns, indicating that the issue was isolated to the transmitter.There were no signs of physical damage or fluid intrusion.Not in patient use.Investigation summary: nihon kohden (nk) received the device on 05/02/2023.Nk repair center (rc) completed the device evaluation on 05/16/2023.Nk rc duplicated the complaint.Nk rc found that the center case failed and that the unit had signs of corrosion on the battery contact surface of the rear case assembly.The center case, rear case, o rings, and case sealants were replaced to repair the device and passed testing.A review of the device's serial number shows that the device is four (4) years old and has no other tickets.Based on the device evaluation, the most probable cause may be related to power supply issues due to corrosion on the battery case.A definitive cause for the corrosion on the battery case could not be determined, but possible causes may include lack of regular maintenance on the device or user error with the storage of the device.The operator's manual recommends performing regular maintenance checks on the device every six months and includes a checklist.One of which is to check for corrosion in the battery case.Corrosion of the battery case may occur if the battery case cover is left detached and the device is exposed to an environment with high humidity, or if the batteries are not removed from the compartment after use, as batteries may slowly leak acidic material over time if not removed from terminal contact.Hazard analysis for the zm-531pa determined that failure modes related to abnormal readings had acceptable risk, and actions have been taken in the design to mitigate risk to patients.A review of the customer's complaint history shows that complaints for the zm-531pa did not result in any patient harm.Nk will continue to monitor and trend similar complaints.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the transmitter: org: model #: org-9110a serial #: (b)(6).Device manufacturer data: 10/11/2014 unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Cns-6201a model #: pu-621ra serial #: (b)(6).Device manufacturer data: 08/12/2014.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.

• 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: 16840398
• MDR Text Key: 314381459
• Report Number: 8030229-2023-03514
• 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: 08/17/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2019
• 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; ORG; ORG