MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION ZM-521PA; TRANSMITTER

Model Number ZM-521PA

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter is causing the cns (central monitoring station) to crash.All other transmitters work fine, just this transmitter is causing the issue.The device was returned to nihon kohden, evaluated, and the reported issue was not able to be confirmed.Unit was tested overnight.The customer requested an exchange so an exchange transmitter was sent to resolve the issue.

Event Description

The customer reported that the transmitter is causing the cns (central monitoring station) to crash.All other transmitters work fine, just this transmitter is causing the issue.

• Brand Name: ZM-521PA
• 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: 5719061
• MDR Text Key: 47196257
• Report Number: 8030229-2016-00253
• Device Sequence Number: 1
• Product Code: DRG
• 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: 06/10/2016,05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-521PA
• Device Catalogue Number: ZM-521PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2016
• Distributor Facility Aware Date: 05/11/2016
• Device Age: 43 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2016
• Initial Date Manufacturer Received: 06/10/2016
• Initial Date FDA Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2012
• 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