MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER

Model Number ZM-530PA

Device Problems Electrical /Electronic Property Problem (1198); Unintended Electrical Shock (4018)

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

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that a patient stated that they were shocked by the telemetry transmitter.The biomed stated that there was no harm to the patient and that it was a minor shock.No signs of physical damage.No signs of fluid intrusion.No patient harm 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.Attempt #1 02/26/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 03/03/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 03/12/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: concomitant medical device: the following device(s) were being used in conjunction with the telemetry transmitter, but model and serial number information was noted as no information (ni), as attempts to obtain information were made but information was not provided.Attempt #1 02/26/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 03/03/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 03/12/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Central nurse's station model: ni sn: ni.

Event Description

The biomedical engineer reported that a patient stated that they were shocked by the telemetry transmitter.The biomed stated that there was no harm to the patient and that it was a minor shock.No signs of physical damage.No signs of fluid intrusion.No patient harm reported.

Event Description

The biomedical engineer reported that a patient was shocked by the telemetry transmitter.There was no serious harm to the patient, and it was reportedly a minor shock.There were no signs of physical damage or fluid intrusion.

Manufacturer Narrative

Details of complaint: the biomedical engineer reported that a patient was shocked by the telemetry transmitter.There was no serious harm to the patient, and it was reportedly a minor shock.There were no signs of physical damage or fluid intrusion.Investigation summary: the issue of electric shock could not be confirmed, and a root cause cannot be determined.The zm-520 and zm-530 series telemetry transmitter is an internally powered equipment which operates on two aa (lr6) type alkaline dry cell primary batteries.The rated voltage is 3.0 v, and the operating voltage is 1.4 - 3.2 v.Per the hazard analysis for zm-530 (0704-905438f), the root cause of electrical shock is often a result of use error.Shock can occur as a result of using the device with wet hands, fluid ingress, or touching the components that conduct electricity during use.A serial number review of the reported device does not reveal additional complaints relating to the reported event.A complaint history review of the customer's account does not reveal complaint reporting of similar events.Additional information: b4 date of this report, g3 date received by manufacturer, g6 type of report, h2 if follow-up, what type?, h6 event problem and evaluation codes, h10 additional manufacturer narrative.

• Brand Name: ZM-530PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 11572108
• MDR Text Key: 244658749
• Report Number: 8030229-2021-00169
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• 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: 04/21/2023

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-530PA
• Device Catalogue Number: ZM-530PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/25/2021
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2012
• 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: CENTRAL NURSE'S STATION; CENTRAL NURSE'S STATION