MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-520PA; TRANSMITTER

Model Number ZM-520PA

Device Problems Application Program Problem (2880); Unintended Application Program Shut Down (4032)

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

Event Date 07/22/2018

Event Type  malfunction  

Manufacturer Narrative

The patient was manually transferred to the bedside and the failed transmitter was removed from service.No additional information was able to be obtained after 3 follow-up attempts to find out the disposition of the device, the serial number of the device, or any additional information regarding the outcome of the event.No patient harm was reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that the transmitter dropped transmission of the patient's vital signs while attempting a patient transfer back to the bedside.The transmitter's display also went blank.

Manufacturer Narrative

Details of the complaint: customer reported a transmitter (zm-520pa) was unable to transfer to a bedside when moving a patient.The transmitter went blank.The patient was moved to the bedside monitor manually and the transmitter was taken out of service.Service requested: troubleshooting/assistance service performed: customer ended the call because it was taking too long to troubleshoot.Multiple follow ups were attempted but no additional information was able to be obtained.Missing information/required information: the device information associated with the complaint file is not entered in the "product" field.This is a known issue and is addressed in capa 18-033.Investigation of the complaint will continue without the product information.Investigation result: the device was in use with a patient and there was no reported harm.As the device was not returned, evaluation of the unit could not be performed.As the device information was not provided, device history cannot be reviewed.Due to the lack of information available, the root cause is unable to be determined.Further investigation is not possible without additional information.

Manufacturer Narrative

H10: additional narrative: on (b)(6) 2018, (b)(6) at (b)(6) hospital reported a transmitter (zm-520pa sn: ?) was unable to transfer to a bedside [monitor] when they were moving a patient.The transmitter went blank.The patient was moved to the bedside monitor manually and the transmitter was taken out of service.Service requested troubleshooting/assistance.Service performed: customer ended the call because it was taking too long to troubleshoot.Multiple follow ups were attempted but no additional information was able to be obtained.Missing information/required information: the device information associated with the complaint file is not entered in the "product" field.Investigation result: review of tickets opened at the facility around the time of reported issue found no other related tickets opened.Review of similar tickets using keywords "zm-520pa drop/transfer/blank" found no relevant tickets reported at other facilities.Due to the lack of information available, the root cause is unable to be determined.No adverse trend suspected for this issue.Additional information: b4.Date of this report.D11.Concomitant medical products.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.H3.Device evaluated by manufacturer? h6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

Event Description

The customer reported that the transmitter dropped transmission of the patient's vital signs while attempting a patient transfer back to the bedside.The transmitter's display also went blank.

• Brand Name: ZM-520PA
• 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: 7803709
• MDR Text Key: 117854371
• Report Number: 8030229-2018-00327
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115077
• UDI-Public: 04931921115077
• 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,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-520PA
• Device Catalogue Number: ZM-520PA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2019
• Distributor Facility Aware Date: 08/22/2019
• Device Age: 0 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2019
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: BEDSIDE MONITOR