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

Model Number ZM-541PA

Device Problem Device Inoperable (1663)

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

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reports that the transmitter has a weak spo2 signal.The readings are not consistent.Moving the devices causes the readings to change drastically.A replacement device was sent to the customer.The device was returned and evaluated.The problem was duplicated.The spo2 module, along with other parts necessary to fix the issue were replaced.The unit was cleaned and all steps per the maintenance check sheet were tested for four days.

Event Description

The biomedical engineer reports that the transmitter has a weak spo2 signal.The readings are not consistent.Moving the devices causes the readings to change drastically.A replacement device was sent to the customer.

• Brand Name: ZM-541PA
• 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: 5509627
• MDR Text Key: 40644336
• Report Number: 8030229-2016-00109
• 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: 03/17/2016,02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• 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: 03/01/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2016
• Distributor Facility Aware Date: 02/16/2016
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2016
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2015
• 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