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

Model Number ZM-530PA

Device Problems Image Display Error/Artifact (1304); Device Operates Differently Than Expected (2913)

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

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter was displaying incorrect ecg readings at the central nurses station (cns).The readings would be very low, then high, and then low.The readings were never constant.The customer was sent an exchange unit.The transmitter was sent 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 when additional information becomes available.

Event Description

The customer reported that the transmitter was displaying incorrect ecg readings at the central nurses station (cns).

Manufacturer Narrative

Corrected data: device evaluated by manufacturer, manufacturer narrative.Additional information: establishment name, email address, address - line 1 and attn name in the address - line 2, city, state and post office.Name, email address, attn name in the address - line 2 and phone number.Type of report.Establishment name, email address, address - line 1 and attn name in the address - line 2, city, state and post office.Name, email address, address - line 1, address - line 2, city, state, post office and phone no.Continued email address and attn name in the address - line 2, and state.Type of report.Follow-up type: event problem and evaluation codes.Manufacturer narrative: the customer reported that the transmitter was displaying incorrect ecg readings at the central nurses station (cns).The readings would be very low, then high, and then low.The readings were never constant.The customer was sent an exchange unit.The transmitter was sent in for evaluation.The unit was cleaned and evaluated.The reported problem of the device is getting incorrect reading at the cns (central nurses station) was unable to duplicated.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: ZM-530PA
• 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: 6506137
• MDR Text Key: 73461929
• Report Number: 8030229-2017-00109
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/19/2017,03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• 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: 04/11/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2017
• Distributor Facility Aware Date: 03/23/2017
• Device Age: 35 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2017
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2014
• 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