MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION PSG-1100A; POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH

Model Number PSG-1100A

Device Problems Overheating of Device (1437); Temperature Problem (3022)

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

Event Date 07/22/2021

Event Type  malfunction  

Event Description

The sleep medicine program manager reported that the jb-110a head box was overheating and causing studies to stall for the psg-1100a.The night tech told the caller that "the headbox in room 5 has been acting funny.For a couple nights the plug has not been staying in the box very well.Also, when it was initially plugged in, it lights up then goes dark.However, randomly in the middle of the night, it is all lit up and then off for no apparent reason.Also, this am, when i went into my patient's room to take him down, the box was extremely warm to the touch.It is not normally like that." no patient harm reported.

Manufacturer Narrative

The sleep medicine program manager reported that the jb-110a head box was overheating and causing studies to stall for the psg-1100a.The night tech told the caller that "the headbox in room 5 has been acting funny.For a couple nights the plug has not been staying in the box very well.Also, when it was initially plugged in, it lights up then goes dark.However, randomly in the middle of the night, it is all lit up and then off for no apparent reason.Also, this am, when i went into my patient's room to take him down, the box was extremely warm to the touch.It is not normally like that." no patient harm 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 being used in conjunction with the psg-1100a: head box model: jb-110a , sn: (b)(4), device manufacturer date: 02/12/2021, approximate age of device: 5 months, unique identifier (udi) #: (b)(4), returned to nihon kohden: not returned.

Manufacturer Narrative

Details of complaint: the sleep medicine program manager reported that the jb-110a head box was overheating and causing studies to stall for the sleep system (psg-1100a).The night technician told the caller that "the headbox in room 5 has been acting funny.' for a couple nights the plug had not been staying connected to the box.The box was found to be extremely warm to the touch.No harm or injury was reported.Investigation summary: the head box was sent into nihon kohden repair center (nk rc) for evaluation and repair.During the review of the device history for (jb-110a, sn: (b)(6)), this complaint was the only incident that occurred involving this device in the past (3) three years and is an isolated issue.A review of the historical data does not reveal any trends that would contribute to component failure related to the device's design or manufacturing.Nk rc was unable to confirm the reported complaint during the evaluation, as the reported issue could not be duplicated.However, nk rc found a secondary issue.One of the 4 slots for the screws on the rear cover was broken.The cpu board was replaced for precautionary measure and the broken rear cover was replaced.Although nk was unable to determine a definitive root cause of the reported issue, it is possible that the secondary damage issue noted could have contributed to the reported issue.

Event Description

The sleep medicine program manager reported that the jb-110a head box was overheating and causing studies to stall for the sleep system (psg-1100a).The night technician told the caller that "the headbox in room 5 has been acting funny.' for a couple nights the plug had not been staying connected to the box.No patient harm reported.

• Brand Name: PSG-1100A
• Type of Device: POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH
• 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: 12351913
• MDR Text Key: 283158273
• Report Number: 8030229-2021-01521
• Device Sequence Number: 1
• Product Code: GWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120888
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PSG-1100A
• Device Catalogue Number: MU-110AK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2019
• 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: HEAD BOX JB-110A SN (B)(6); JB-110A SN (B)(6)