MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION ZM-541PA; TRANSMITTER

Model Number ZM-541PA

Device Problems Device Inoperable (1663); Device Handling Problem (3265)

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

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter is giving off inaccurate ecg readings.The customer changed the batteries, leads, and put it on a simulator.The customer advised there was no change in the inaccuracies.The device was returned to nihon kohden, evaluated, and the reported issue was confirmed.When the transmitter was received and examined it was noted that the transmitter had evidence of fluid intrusion and was contaminated.The unit was properly disposed of in nihon kohden's biohazard location.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 that the transmitter is giving off inaccurate ecg readings.

• Brand Name: ZM-541PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 486 nanokaichi; tomioka city, japan 370-2 343; JA 370-2343
• Manufacturer (Section G): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; tokyo, japan 161-8 560; JA 161-8560
• Manufacturer Contact: thomas bento ; 1-31-4 nishiochia, shinjuku-ku; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687708
• MDR Report Key: 5328173
• MDR Text Key: 34384345
• Report Number: 8030229-2015-00466
• 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: 12/24/2015,11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-541PA
• Device Catalogue Number: ZM-541PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/24/2015
• Distributor Facility Aware Date: 11/24/2015
• Device Age: 21 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/24/2015
• Date Manufacturer Received: 12/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2014
• 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