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

Model Number ZM-530PA

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the transmitter displayed inaccurate readings.No consequence or impact to the patient was reported.Nihon kohden continues to investigate the reported event and will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

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

Manufacturer Narrative

It was reported that the transmitter displayed inaccurate readings.The reported product was returned and evaluated.Investigation results: the unit was evaluated by the repair center.The reported issue could not be duplicated.The device was evaluated on an ecg simulator and signal amplitude and waveforms were normal.After 48 hours of "burn-in" signals remained stable.An inspection of the interior of the device show no signs of fluid intrusion.No malfunction found.

• Brand Name: ZM-530PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 116-8 560; JA 116-8560
• MDR Report Key: 8338028
• MDR Text Key: 136144075
• Report Number: 8030229-2019-00043
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• Combination Product (y/n): N
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• 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: 03/12/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2019
• Distributor Facility Aware Date: 01/14/2019
• Device Age: 66 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2019
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1