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  

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.Attempt #1: (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with additional complaint details, but they did not provide patient information.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.

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.

• 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
• MDR Report Key: 12351923
• MDR Text Key: 267853831
• Report Number: 2080783-2021-01521
• Device Sequence Number: 1
• Product Code: GWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2021

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2021
• Distributor Facility Aware Date: 07/22/2021
• Device Age: 25 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1