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

Model Number ZM-530PA

Device Problem Device Inoperable (1663)

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

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter is giving a waveform even when an ecg cable is not connected.Issue was found by the nurse who was prepping the unit.The device was returned to nihon kohden, evaluated, and the reported issue could not be duplicated.When the device was received it was noted to be scratched on the front case and permanent marker on the center case.Cleaned the unit and replaced parts to meet manufacturer's specification, completed all steps per maintenance check sheet in the operator's manual and performed an extended test for 3 days.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 the transmitter is giving a waveform even when a ecg cable is not connected.Issue was found by the nurse who was prepping the unit.

• Brand Name: ZM-530PA
• 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: 5312720
• MDR Text Key: 33936016
• Report Number: 8030229-2015-00457
• 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: 12/19/2015,11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2015
• 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
• Date Returned to Manufacturer: 12/08/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2015
• Distributor Facility Aware Date: 11/19/2015
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2015
• Date Manufacturer Received: 12/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2015
• 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