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

Device Problems Power Problem (3010); Complete Loss of Power (4015)

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

Event Date 12/27/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their hospitals experienced a power surge, and one of their switches pooped out.This caused all of their telemetry units to go down.No further information was provided at this time.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.Additional device information: concomitant medical device: the following device(s) were used in conjunction with the cns, transmitters: model: ni.S/n: ni.Approximate age of the device: ni.Device manufacturer date: ni.

Event Description

The customer reported that their hospitals experienced a power surge, and one of their switches pooped out.This caused all of their telemetry units to go down.No further information was provided.

Event Description

The customer reported that the hospital experienced a power surge that affected one of the switches, which then caused the telemetry system to go down.No further information was provided.

Manufacturer Narrative

Details of complaint: the customer reported that the hospital experienced a power surge that affected one of the switches, which then caused the telemetry system to go down.No further information was provided.No patient harm was reported.Investigation summary: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.As reported by the customer, the cause of the switch failure was due to a power surge.Therefore, the root cause is related to environmental factors.The switch is not an nk device.A signal loss error message at the central nurse's station (cns) would be an indicator there is an issue with the hospital's network.There is no evidence of an nk device malfunction that may have contributed to the reported issue.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6 patient information b6 - b7 adverse event or product problem d1 brand name d4 model name catalog name serial number unique identifier (udi) number g4 pma/510(k) number h4 device manufacturer date.Attempt #1 01/12/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 01/19/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 01/26/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the cns: telemetry transmitters: model: ni s/n: ni approximate age of the device: ni device manufacturer date: ni.

• Brand Name: NI
• Type of Device: CENTRAL MONITOR STATION
• 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: 13362388
• MDR Text Key: 289467919
• Report Number: 8030229-2022-02433
• 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: 01/26/2022
• 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: 08/30/2023
• 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: TELEMETRY TRANSMITERS; TRANSMITERS