MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION; CENTRAL MONITOR SYSTEM

Device Problems Loss of Power (1475); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2021

Event Type  malfunction  

Event Description

The customer reported that their uninterruptible power supply (ups) went down causing a brief power loss at the central nurse's station (cns).No harm or injury was reported.

Manufacturer Narrative

The customer reported that their uninterruptible power supply (ups) went down causing a brief power loss at the central nurse's station (cns).No harm or injury was reported.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.Concomitant medical device: the following device(s) were used in conjunction with the cns: ups: model #: a/abce602-11 serial #: (b)(4).

Manufacturer Narrative

Details of complaint: the customer reported that the uninterruptible power supply (ups) went down, causing a brief power loss at the central nurse's station (cns).No patient harm was reported.Investigation summary: as no devices were returned for evaluation relating to this event and no troubleshooting was performed, the reported issue could not be confirmed.As such, a root cause cannot be determined.Failure of the ups is likely related to hardware failure.Hardware failure could come as a result of physical damage, heat damage, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Heat damage could occur due to improper maintenance or placement of the device.Electrical damage could occur during a power outage or power surge.Wear and tear due to aging of the device or frequency of use can gradually degrade components.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the model #: a/abce602-11 serial #: (b)(6).

Event Description

The customer reported that the uninterruptible power supply (ups) went down, causing a brief power loss at the central nurse's station (cns).No harm or injury was reported.

• Brand Name: NI
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12125720
• MDR Text Key: 281421356
• Report Number: 8030229-2021-00390
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: UNINTERRUPTIBLE POWER SUPPLY (UPS).; UNINTERRUPTIBLE POWER SUPPLY (UPS).