MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION ZM-540PA; TRANSMITTER

Model Number ZM-540PA

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported a burning smell in the battery compartment of the transmitter.There were no burn marks in the battery compartment and no signs of fluid intrusion.The device was returned to nihon kohden, evaluated and the reported problem was duplicated.The burn smell might be caused by fluid intrusion inside front case and battery compartment.Unit was received with broken parts.Ecg / resp socket and spo2 socket were very dirty.The front case battery cover and spo2 module were replaced.Clean exg / spo2 socket were cleaned.Completed all steps per the maintenance check sheet in the operator's manual and tested for 1 day as per the manufacture's specifications.The customer was provided with a transmitter exchange.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

Event Description

The customer reported a burning smell in the battery compartment of the transmitter.There were no burn marks in the battery compartment and no signs of fluid intrusion.

• Brand Name: ZM-540PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer Contact: susan shadley ; 1-31-4 nishiochiai, shinjuku-k; attn: susan shadley; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687133
• MDR Report Key: 5622372
• MDR Text Key: 44121693
• Report Number: 8030229-2016-00180
• 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
• Report Date: 04/29/2016,03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-540PA
• Device Catalogue Number: ZM-540PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2016
• Distributor Facility Aware Date: 03/30/2016
• Device Age: 55 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2016
• Initial Date Manufacturer Received: 04/29/2016
• Initial Date FDA Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2011
• 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