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

Model Number ZM-530PA

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the transmitter displayed inaccurate ecg readings while monitoring a patient.No consequence or impact to the patient was reported.The device has been returned to nihon kohden and is awaiting evaluation.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.

Event Description

It was reported that the transmitter displayed inaccurate ecg readings while monitoring a patient.No consequence or impact to the patient was reported.

Manufacturer Narrative

Details of complaint: the customer reported that the transmitter displayed inaccurate ecg readings while monitoring a patient.No consequence or impact to the patient was reported.The device has been returned to nihon kohden for evaluation.Service requested / performed: evaluation / repair: the device was returned to nihon kohden repair center for physical evaluation and functional testing.Nihon kohden repair center was able to duplicate the reported complaint during the functional testing.The inspection discovered some residue from an unknown liquid on the transmitter, indicating a possible fluid intrusion into the device.Because the transmitter is not waterproof, fluid intrusion could cause malfunction to the interior hardware, which could cause a power problem.The user should stop using the transmitter if it has been exposed to liquid or detergent, according to the service manual.Investigation summary: fluid intrusion was the root cause of the problem.As this issue has an overall risk score of medium, a capa is not required per corrective action and preventive action process, sop07-003.The following fields contain no information (ni), as attempts to obtain information were made, but not provided.

Event Description

It was reported that the transmitter displayed inaccurate ecg readings while monitoring a patient.No consequence or impact to the patient was reported.

Manufacturer Narrative

Details of complaint: the customer reported that the transmitter displayed inaccurate ecg readings while monitoring a patient.The customer could not provide details on what was incorrect and declined troubleshooting.No patient harm was reported.The device has been returned to nihon kohden for evaluation.Service requested / performed: evaluation / repair: residue was observed on the spo2 and ecg connectors (figure 1): figure 1.Operator's manual defines the following measured parameters: a note from the operator's manual indicates possible cause for the observed issue: the presence of residue on the connectors likely affected the impedance values, which in turn affected the accuracy of the readings.Investigation summary: the root cause of the reported inaccurate ecg readings is attributable to the device being exposed to fluid.The service history for this serial number shows this is an isolated incident.No capa is required at this time.

Event Description

It was reported that the transmitter displayed inaccurate ecg readings while monitoring a patient.No patient harm was reported.

• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 8936262
• MDR Text Key: 198330021
• Report Number: 8030229-2019-00399
• 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,Followup
• Report Date: 08/27/2019,01/25/2022

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-530PA
• Device Catalogue Number: ZM-530PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2019
• Distributor Facility Aware Date: 08/01/2019
• Device Age: 38 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2019
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 12/21/2021; 01/25/2022
• Supplement Dates FDA Received: 01/12/2022; 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2016
• 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