MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-531PA; TRANSMITTER

Model Number ZM-531PA

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Data Problem (3196)

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

Event Date 09/02/2021

Event Type  malfunction  

Event Description

The customer reported that the transmitter's spo2 readings are coming out incorrectly and would like to know why.There was no patient injury reported.

Manufacturer Narrative

The customer reported that the transmitter's spo2 readings are coming out incorrectly and would like to know why.According to the customer, when it drops to 80, there seems to be a huge discrepancy analytically wise and it is not matching with what they have as their records.When taking spo2 readings from the patient separately, they get a different value than the spo2 reading on the central nurse's station (cns).There was no patient injury 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.

Manufacturer Narrative

Details of complaint: the customer reported that the transmitter's spo2 readings, when dropping to below 80, did not match the readings 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, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.The customer reported that the issue did not have a clear resolution but that the ticket could be closed.No further issues were reported.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.Possible causes may be related to improper placement of the spo2 probe, patient condition, and environmental interference.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6, b6 - b7, d10.Attempt # 1: (b)(6) 2021 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: (b)(6) 2021 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3 (b)(6) 2021 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the transmitter: cns: model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni, returned to nihon kohden: ni.Additional information: b4 date of this report, g3 date received by manufacturer, g6 type of report, h2 if follow-up, what type?, h6 event problem and evaluation codes, h10 additional manufacturer narrative.

Event Description

The customer reported that the transmitter's spo2 readings, when dropping to below 80, did not match the readings at the central nurse's station (cns).There was no patient injury reported.

• Brand Name: ZM-531PA
• Type of Device: TRANSMITTER
• 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: 12566157
• MDR Text Key: 281657920
• Report Number: 8030229-2021-01745
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115107
• UDI-Public: 04931921115107
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043517
• 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,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-531PA
• Device Catalogue Number: ZM-531PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• 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: CNS; CNS