MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-930PA

Model Number ZM-930PA

Device Problems Overheating of Device (1437); Temperature Problem (3022)

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

Event Date 03/14/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter overheats.The transmitter was removed from service and not used on a patient.The biomedical engineer tried testing the transmitter to see if the transmitter would get hot but was unsuccessful in duplicating the issue.Biomed notes that when the device was turned on it made a beeping sound and dashes were displayed on the transmitter screen.The unit no longer turns on.Customer was sent an exchange transmitter.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 overheats.

Manufacturer Narrative

Corrected data: device available for evaluation, 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 overheats.The transmitter was removed from service and not used on a patient.The biomedical engineer tried testing the transmitter to see if the transmitter would get hot but was unsuccessful in duplicating the issue.Biomed notes that when the device was turned on it made a beeping sound and dashes were displayed on the transmitter screen.The unit no longer turns on.The customer was sent an exchange transmitter.The unit was externally cleaned and visually evaluated.The evaluation indicates the unit had fluid intrusion and is contaminated.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: ZM-930PA
• Type of Device: ZM-930PA
• 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; 486 nanokaichi; attn: shama mooman; gunma 370-2 343; JA 370-2343
• 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: 6483209
• MDR Text Key: 72782917
• Report Number: 8030229-2017-00102
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946175
• 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: 04/11/2017,03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-930PA
• Device Catalogue Number: ZM-930PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2017
• Distributor Facility Aware Date: 03/14/2017
• Device Age: 147 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2017
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2004
• 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