MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION; VITAL SIGNS MONITOR

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the ay input units were having nibp issues.When they tested it on themselves, it was giving incorrect readings and that they were getting different readings compared to other ay units they tested.There was no error message.When they had the nurses test it out, it was not giving any readings at all.The ay input unit is part of bedside monitor system, but it is unknown which bedside monitor monitor they are using the unit with.Only the ay unit was sent if for repair.Not in patient use.

Manufacturer Narrative

The biomedical engineer (bme) reported that the ay input units were having nibp issues.When they tested it on themselves, it was giving incorrect readings and that they were getting different readings compared to other ay units they tested.There was no error message.When they had the nurses test it out, it was not giving any readings at all.The ay input unit is part of bedside monitor system, but it is unknown which bedside monitor monitor they are using the unit with.Only the ay unit was sent if for repair.Not in patient use.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.Attempt #1: 03/01/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: 03/06/2024 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the additional device information as requested.Additional device information: d10 concomitant medical device: ay input unit, model: ay-653p; sn:(b)(6); device manufacturer date: 01/21/2011; unique identifier (udi) #: (b)(4); returned to nihon kohden: 03/19/2024.

• Brand Name: NI
• Type of Device: VITAL SIGNS MONITOR
• 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; 1-1 tajino; attn: shama mooman; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18983889
• MDR Text Key: 339286132
• Report Number: 8030229-2024-04191
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• 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: AY-653P SN (B)(6)