MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-920PA

Model Number ZM-920PA

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the transmitter's casing was warped, indicating the device was overheating.There was no fluid intrusion reported.The device was not in use on a patient at the time.The biomedical engineer was advised that we no longer do exchanges for this model, however we will repair the device provided the needed parts are available.Nihon kohden is currently waiting for the device to arrive.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 biomedical engineer reported that the transmitter's casing was warped, indicating the device was overheating.

Manufacturer Narrative

Corrected data: device available for evaluation, device evaluated by manufacturer, additional manufacturer narrative.Additional information: type of report?: follow up, type of report: follow up, additional information/correction, event problem and evaluation codes.The biomedical engineer (bme) reported that the transmitter's casing was warped, indicating the device was overheating.There was no fluid intrusion reported.The device was not in use on a patient at the time.The bme was advised that we no longer do exchanges for this model.The device was repaired and returned to the customer.Investigation revealed that the malfunction of the device was due to improper installation of the batteries in the unit.

• Brand Name: ZM-920PA
• Type of Device: ZM-920PA
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 486 nanokaichi; attn: shama mooman; tomioka city, gunma 370-2 343; JA 370-2343
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 6831677
• MDR Text Key: 84078492
• Report Number: 8030229-2017-00280
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945578
• 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: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-920PA
• Device Catalogue Number: ZM-920PA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 08/30/2017
• Distributor Facility Aware Date: 08/03/2017
• Device Age: 111 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2017
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2008
• 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
• Patient Outcome(s): Congenital Anomaly; Other