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

Model Number ZM-530PA

Device Problem Battery Problem (2885)

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

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their transmitter overheated and melted the battery compartment.The customer also confirmed that no injury or harm occured.They will be sending this unit in for an exchange.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that their transmitter overheated and melted the battery compartment.

Event Description

The customer reported that their transmitter overheated and melted the battery compartment.

Manufacturer Narrative

Details of complaint: the customer reported that their transmitter overheated and melted the battery compartment.The customer also confirmed that no injury or harm had occurred.They will be sending this unit in for an exchange.Service requested / performed: evaluation: the evaluation revealed that a plastic piece where the contact spring is located was deformed from overheating and the unit would not power on.The unit was scrapped.Investigation summary: the overheating of the battery compartment could be caused due to a number of reasons, such as: the battery is inserted in a wrong polarity causing overcurrent.Battery is inserted forcibly, causing fire due to short-circuit of +/- terminals.Short-circuit between the +/- battery terminals.User does not handle nimh secondary battery and a battery charger properly, causing a short-circuit of the +/- terminals.Investigation determined that the reported issue could have been caused due to incorrect usage and maintenance of the nk device.

• 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: 10830126
• MDR Text Key: 228481966
• Report Number: 8030229-2020-00674
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 08/15/2022
• Supplement Dates FDA Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2015
• 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