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

Model Number ZM-530PA

Device Problems Overheating of Device (1437); Temperature Problem (3022)

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

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the telemetry transmitter got hot and they smelled smoke coming from the unit.Them the unit turned off and would not turn on again.This occurred at the set-up stage before being put into patient use.No harm or 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.

Event Description

The biomedical engineer reported that the telemetry transmitter got hot and they smelled smoke coming from the unit.Them the unit turned off and would not turn on again.This occurred at the set-up stage before being put into patient use.No harm or injury reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer reported that the telemetry transmitter got hot to the touch.They also reported smelling smoke coming from the unit.The unit then powered off and would not power back on.This occurred at the set-up stage before being placed into patient use.No harm or injury was reported.Service requested / performed: exchange.Investigation summary: a previous investigation under irc-nka300097945 identified that the incorrect insertion of the battery may cause the battery spring terminal to break the coating of the battery, leading to short circuit and eventually heating of the device.The most probable cause of the issue is improper battery insertion.The operator's manual provides instruction on how to properly insert the batteries on the device.Furthermore, a design change was made to prevent overheating by short circuit caused by improper insertion of batteries (ref tn-1231).The design change has been applied to the following serial numbers: (b)(6) or later a design change has been implemented to the product to prevent short circuit of the battery during battery insertion.The complaint device was manufactured prior to this change.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 biomedical engineer reported that the telemetry transmitter got hot to the touch.They also reported smelling smoke coming from the unit.The unit then powered off and would not power back on.This occurred at the set-up stage before being placed into patient use.No harm or injury reported.

• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 11255122
• MDR Text Key: 240343807
• Report Number: 8030229-2021-00037
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2014
• 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: NA.; NA.