MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER

Model Number ZM-530PA

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

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

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their transmitter is giving incorrect readings.No harm or injury was reported.Nihon kohden continues to investigate the reported event.

Event Description

The customer reported that their transmitter is giving incorrect readings.

Manufacturer Narrative

Details of complaint: the customer reported that their transmitter was giving incorrect readings.No harm or injury was reported.Investigation summary: as the device was not returned for evaluation, a root cause cannot be determined.The issue of inaccurate values could not be confirmed.Per the operator's manual for the zm-530p, possible root causes are: 1.Inappropriate probe size, the user should verify that the probe size is correct for the patient.2.Poor attachment of probes to the patient, causing external light to enter the probe.The customer should verify that the probe is firmly attached according to the procedure in the operator's manual.3.A dirty measurement sight or presence of nail polish.The customer should remove any dirt or nail polish before attaching the probe.4.The probe is attached to the same limb as the nibp measurement.The customer should attach the probe to the opposite limb and avoid sites with varying blood flow conditions.The causes outlined in the operator's manual indicate that the root cause is likely related to use error and patient conditions.A serial number review of the reported device does not reveal additional complaints relating to inaccurate values.A complaint history review of the customer's account does not reveal complaint reporting of similar events.

Event Description

The customer reported that the transmitter was giving incorrect readings.

• Brand Name: ZM-530PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• 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: 11455345
• MDR Text Key: 244611515
• Report Number: 8030229-2021-00131
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-530PA
• Device Catalogue Number: ZM-530PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2016
• 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