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

Model Number ZM-531PA

Device Problems Incorrect Or Inadequate Test Results (2456); Device Operates Differently Than Expected (2913)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter displayed incorrect ecg readings while on a simulator.During testing, the device displayed only noise/artifact.They tried new lead sets; however the issue continued to persist.The simulator's heart rate was set to read 80 beats per minute, but it displayed a reading of 90 beats per minute.The customer will send the device in for evaluation.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 displayed incorrect ecg readings while on a simulator.

Manufacturer Narrative

(b)(4).Manufacturer narrative: the customer reported that the transmitter displayed incorrect ecg readings while on a simulator.During testing, the device displayed only noise/artifact.They tried new lead sets; however, the issue continued to persist.The simulator's heart rate was set to read 80 beats per minute, but it displayed a reading of 90 beats per minute.The reported problem could not be duplicated.In addition, no fluid intrusion was observed on the main board.However, there is significant physical damage that will require replacement of the case.The customer was sent an exchange unit.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: ZM-531PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgm; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580 ; 2687488
• MDR Report Key: 6459179
• MDR Text Key: 71916323
• Report Number: 8030229-2017-00097
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115107
• UDI-Public: 04931921115107
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/04/2017,03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2017
• Distributor Facility Aware Date: 03/10/2017
• Device Age: 53 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2017
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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