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

Model Number ZM-531PA

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2018

Event Type  malfunction  

Manufacturer Narrative

Testing of the transmitter with just a thumb over the connector revealed that the central nurse's station (cns) was receiving a heart beat waveform when it should not.The customer will be provided with an exchanged device to resolve the issue.No patient harm was reported.

Event Description

The biomedical engineer reported that the transmitter sent an ecg waveform to the central nurse's station (cns) with no leads attached.

Event Description

The biomedical engineer reported that the transmitter sent an ecg waveform to the central nurse's station (cns) with no leads attached.

Manufacturer Narrative

H10: additional narrative: on (b)(6) 2018, (b)(6) at (b)(6) center reported the transmitter (zm-531pa sn: (b)(6) was picking up waveforms with no leads attached.He states that there are 2 more devices that do the same thing and believes it to be a patient safety issue if the leads fall off and they are still getting noise and waveforms and the cns does not alarm correctly.He also tested with just his thumb over the connector and saw that the cns and was picking up a heart beat.We checked rssi and he was getting 15 on, 13 with his thumb over the connector, and 8 off.Service requested exchange.Service performed exchange.Nka repair center evaluation: the unit was cleaned and decontaminated.The model, serial number, and all labels were verified.Physical evaluation: unit appears to be in good shape.Verify the complaint: verify the complaint was not duplicated: cnd, transmitter picking up waveforms with no leads attached.Investigation result: the device warranty began 07/04/2012, which is over 6 years prior to reported issue.Review of device history found no previously reported issues of the unit picking up waveforms with no leads attached.Customer reported the issue was occurring on total of three devices.Nka repair center evaluation was unable to duplicate the reported issue for all three transmitters reported to have issue: (1) 300139916/39549 reported 09/18/2018 for zm-531pa sn: (b)(6).Nka repair center evaluation: physical evaluation: unit has cracked front case assembly, no fluid intrusion.Verify the complaint: i replicated the same testing that (b)(6) did.Waveforms flatline with no sign of activity when leads are disconnected.I tested with just my thumb over the connector, but the cns and was not picking up a heart beat, only flatline.I could not duplicate the complaint.(2) 300139924/39550 reported 09/18/2018 for zm-531pa sn: (b)(6).Nka repair center evaluation: the unit was cleaned and decontaminated.The model, serial number, and all labels were verified.Physical evaluation: unit appears to be in good shape.Verify the complaint: verify the complaint was not duplicated: cnd, transmitter picking up waveforms with no leads attached (3) 300139926/39552 reported 09/18/2018 for zm-531pa sn: (b)(6).Nka repair center: unit had scratches on front case assembly and sticky residue in ecg socket.The unit was cleaned and evaluated.All malfunctioning parts were replaced.The unit was tested per the operator's manual.The unit completed 24 hours of extended testing and operates to manufacturer's specifications.Nka repair center evaluation of the suspected transmitters was unable to reproduce the issue for each case.This suggests issue may be a result of circumstances at the facility.Possible cause is an external factor causing signal interference on the transmitters' channels.Information on the conditions at the facility at the time of reported issue is not known.Zm-531pa operator's manual advises the following: (1) do not use the same channel for different patients.If the same channel is used for two patients, the two patients' data will be lost due to mutual modulation interference, or another patient's data may appear on the receiving monitor screen.(2) do not use two transmitters with adjacent channels in the same hospital.If transmitters with adjacent channels are used, their radio waves interfere with each other.(3) turn off the power of mobile phones, small wireless devices and other devices which produce strong electromagnetic interference around a patient (except for devices allowed by the hospital administrator).Radio waves from devices may be mistaken as pulse waves or respiration waves and the displayed data may be incorrect.(4) common interference sources and remedial actions, within section emc related caution.Based on the given information, the root cause cannot be confirmed.This issue is not suspected to be caused by deficiency of the transmitter or its design.There does not appear to be an adverse trend for the issue at this facility or at other facilities.Corrected information: b3.Date of event.Additional information: b4.Date of this report.F6.Date user facility/importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.Type of report.H2.If follow-up, what type? additional information.Correction.Device evaluation.H3.Device evaluated by manufacturer? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

• Brand Name: ZM-531PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 7950176
• MDR Text Key: 123252966
• Report Number: 8030229-2018-00396
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115107
• UDI-Public: 04931921115107
• 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: 08/08/2019

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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2019
• Distributor Facility Aware Date: 08/07/2019
• Device Age: 52 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2019
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/09/2018
• Supplement Dates Manufacturer Received: 08/07/2019
• Supplement Dates FDA Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1