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

Model Number ZM-540PA

Device Problems Burst Container or Vessel (1074); Overheating of Device (1437); Device Inoperable (1663); Temperature Problem (3022); Device Handling Problem (3265)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter's battery compartment was very hot, and the batteries looked like they exploded.No patient harm was reported.Customer was provided with a transmitter exchange.Nihon kohden continues to investigate the reported event.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 that the transmitter's battery compartment was very hot, and the batteries looked like they exploded.No patient harm was reported.

Manufacturer Narrative

The customer reported that the transmitter's battery compartment was very hot, and the batteries looked like they exploded.No patient harm was reported.Customer was provided with a transmitter exchange.The device was returned to nihon kohden, evaluated, and the reported issue, battery compartment was very hot, was confirmed.It was determined that the cracked case was caused by the battery being put into the transmitter the wrong way causing it to melt the battery housing.No fluid intrusion was found in the device.The customer was supposed to have sent in the batteries so nihon kohden could examine them and determine if the customer was using the type of battery recommended in the zm-540pa transmitter user manual, nihon kohden medipower (equivalent to panasonic lr6).However, customer did not return the batteries.The transmitter returned by the customer was cleaned and all steps per the maintenance check sheet in the operator's manual were completed.The device was tested for 4 days without any reported problems.The reported problem was determined to have been caused by a use error.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• 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: 5540402
• MDR Text Key: 42030646
• Report Number: 8030229-2016-00133
• 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: 03/31/2016,03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• 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?: No
• Date Returned to Manufacturer: 03/14/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2016
• Distributor Facility Aware Date: 03/01/2016
• Device Age: 44 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2016
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2012
• 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