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

Model Number ZM-531PA

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

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

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the unit would not transmit vitals to central nursing system (cns) and the batteries were inserted incorrectly which caused the unit get hot.The unit was in patient use but no harm was caused to the patient.Nihon kohden continues to investigate the reported event.

Event Description

The customer reported that the unit would not transmit vitals to central nursing system (cns) and the batteries were inserted incorrectly which caused the unit get hot.The unit was in patient use but no harm was caused to the patient.

Manufacturer Narrative

Details of complaint: the customer reported that the telemetry transmitter would not transmit vitals to the central nurse's station (cns).Additionally, the batteries were inserted incorrectly which caused the unit to overheat.The unit was in patient use, but no harm to the patient or user was reported.Service requested / performed: exchange.Investigation summary: a previous investigation 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 (b)(4)).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.

Event Description

The customer reported that the telemetry transmitter would not transmit vitals to the central nurse's station (cns).Additionally, the batteries were inserted incorrectly which caused the unit to overheat.The unit was in patient use, but no harm to the patient or user was 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 ; 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: 11325522
• MDR Text Key: 244669425
• Report Number: 8030229-2021-00077
• Device Sequence Number: 1
• Product Code: DRT
• 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: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2015
• 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