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

Model Number ZM-531PA

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459); Low Readings (2460)

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

Event Date 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the heart rate (hr) and o2 readings are inaccurate on this transmitter.According to the customer, they're getting high readings for the hr value and low readings for the o2 value.They have been double-checking the reading using a bedside and the bedside gives them a normal reading for the patient.The customer will send in the unit to be repaired.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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6)2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the zm transmitter: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.

Event Description

The customer reported that the heart rate (hr) and o2 readings are inaccurate on this transmitter.According to the customer, they're getting high readings for the hr value and low readings for the o2 value.There was no patient injury reported.

Event Description

The customer reported that the heart rate (hr) and o2 readings are inaccurate on this transmitter.According to the customer, they're getting high readings for the hr value and low readings for the o2 value.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the heart rate (hr) and o2 readings are inaccurate on this transmitter.According to the customer, they're getting high readings for the hr value and low readings for the o2 value.They have been double-checking the reading using a bedside and the bedside gives them a normal reading for the patient.The customer will send in the unit to be repaired.There was no patient injury reported.Investigation summary: nihon kohden (nk) received the complaint device and 3 disposable probes from the customer on 07/14/2023.The nk repair center (rc) evaluated the device on 07/21/2023 and was unable to duplicate the complaint.The nk rc also found that the unit had a small dent on the front case.The disposable probes were tested with the unit and were found to operate normally.As a precautionary measure, the center case was replaced with a new one.The small dent found on the case is a cosmetic issue and is unlikely to be related to the complaint of incorrect readings.The nk rc tested the device again on (b)(6) 2023 and confirmed the device operates to manufacturer's specifications.A definitive root cause for the issue could not be determined since the complaint could not be duplicated and nk rc did not find any issues with the probes.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 06/14/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/26/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 06/29/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: 06/14/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/26/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 06/29/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: 06/14/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/26/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 06/29/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the zm 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.D9 device available for evaluation.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h3 device evaluated by manufacturer.H10 additional manufacturer narrative.Manufacturer references # 300334398 - 175910 follow up 001.

• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17303046
• MDR Text Key: 318862521
• Report Number: 8030229-2023-03627
• 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: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2021
• 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