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

Model Number ZM-920PA

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Electric Shock (2554); No Known Impact Or Consequence To Patient (2692)

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter is shocking people when the power is on.The shock was from the transmitter case and not on the lead set.No patient harm was reported when the issue occurred.Issue was resolved at the hospital by replacing the transmitter with a spare unit.The biomedical engineer reported it appears that the device has come in contact with water.The device was returned to nihon kohden, evaluated, and it was found that the battery contacts were corroded.Unit is still being evaluated.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 when additional information becomes available.

Event Description

The customer reported that the transmitter is shocking people when the power is on.The shock was from the transmitter case and not on the lead set.

Manufacturer Narrative

Manufacturer narrative: the customer reported that the transmitter is shocking people when the power is on.The shock was from the transmitter case and not on the lead set.No patient harm was reported when the issue occurred.Issue was resolved at the hospital by replacing the transmitter with a spare unit.The biomedical engineer reported it appears that the device has come in contact with water.The device was returned to nihon kohden, evaluated, and it was found that the battery contacts were corroded.The device was further evaluated and the reported problem of unit shocking people could not be duplicated.The unit displays significant physical damage to battery compartment.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• 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, 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 mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580 ; 2687488
• MDR Report Key: 5537567
• MDR Text Key: 41773235
• Report Number: 8030229-2016-00128
• 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: 03/30/2016,02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2016
• Distributor Facility Aware Date: 02/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2016
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 03/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention