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

Model Number ZM-930PA

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Smoking (1585)

Patient Problems Burn(s) (1757); No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2016

Event Type  malfunction  

Manufacturer Narrative

Customer reported that the transmitter got hot, staff smelled smoke, the batteries got hot and expanded, and caused case damage.In the process the nurse that was handling the device got burned.The incident took place on (b)(6) 2016 at 11:00am.As a result of the burn, the nurses hand turned red.She flushed it with cool water and the redness went away shortly.The nurse stated that the injury was not life-threatening and did not result in permanent inpairment of the body.The injury did not necessitate medical or surgical intervention.The customer stated that they were not using the recommended batteries, they were using the cheap batteries.The device has been returned to nihon kohden and is undergoing 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

Customer reported that the transmitter got hot, staff smelled smoke, the batteries got hot and expanded, and caused case damage.In the process the nurse that was handling the device got burned.

Manufacturer Narrative

The customer reported that the transmitter got hot, staff smelled smoke, the batteries got hot and expanded, and caused case damage.In the process the nurse that was handling the device got burned.The incident took place on (b)(6) 2016 at 11:00am.As a result of the burn, the nurses hand turned red.She flushed it with cool water and the redness went away shortly.The nurse stated that the injury was not life-threatening and did not result in permanent impairment of the body.The injury did not necessitate medical or surgical intervention.The customer stated that they were not suing the recommended batteries, they were using the cheap batteries.The device was returned to nihon kohden for evaluation.The device was evaluated for possible short circuits and none were found.Battery used by customer is not equivalent to recommended battery.

• Brand Name: ZM-930PA
• Type of Device: ZM-930PA
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; tokyo, japan 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 486 nanokaichi; tomioka city, japan 370-2 343; JA 370-2343
• Manufacturer Contact: thomas bento ; 1-31-4 nishiochia, shinjuku-ku; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687708
• MDR Report Key: 5682226
• MDR Text Key: 46887112
• Report Number: 8030229-2016-00216
• 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: 05/26/2016,04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: Yes
• 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: 05/12/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 05/26/2016
• Distributor Facility Aware Date: 04/27/2016
• Device Age: 62 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2016
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2011
• 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): Other