MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CENTRAL MONITORING SYSTEM; CENTRAL MONITORING STATION

Model Number EDNS-9001

Device Problems Loss of Power (1475); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

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

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

The customer states that the prefense monitor will only come on for a short duration, then powers off.The biomedical engineer verified that a different monitor works (another bme has a spare monitor on the system and they are monitoring patients).The customer was transferred to customer service for the pricing of a new monitor.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.

Event Description

The customer states that the prefense monitor will only come on for a short duration, then powers off.

Manufacturer Narrative

The customer states that the prefense monitor will only come on for a short duration, then powers off.The biomedical engineer verified that a different monitor works (another bme has a spare monitor on the system and they are monitoring patients).The customer was transferred to customer service for the pricing of a new monitor.The device was never sent in for evaluation as the customer was looking into getting a new monitor.Due to the age of this complaint additional information necessary to conduct an investigation is not readily available.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: CENTRAL MONITORING SYSTEM
• Type of Device: CENTRAL MONITORING STATION
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan CA 161-8 560; JA 161-8560
• Manufacturer (Section G): NKUS LAB; 5 jenner, suite 180; attn: shama mooman; gunma CA ; JA
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgm; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama, CA 359-8-580 ; JA 359-8580 ; 9492687708
• MDR Report Key: 5462342
• MDR Text Key: 39424004
• Report Number: 2032233-2016-00079
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102106
• 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: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EDNS-9001
• Device Catalogue Number: EDNS-9001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2011
• 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