MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-521PA; TRANSMITTER

Model Number ZM-521PA

Device Problems Overheating of Device (1437); Structural Problem (2506); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that the transmitter got overheated.No consequence or impact to the patient was reported.Nihon kohden continues to investigate the reported event and will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported that the transmitter got overheated.No consequence or impact to the patient.

Manufacturer Narrative

Correction data: f7: type of report.G7: type of report.H2: if follow up; what type? h6: method code, result code and conclusion code.H10: additional information: details of complaint: complaint states nkc technician performed case upgrades to telemetry transmitters that are getting reports of overheating.Service requested repair - rear case change.Service performed repair - rear case change.Investigation results upon investigation it was determined that 10 transmitters had rear cases replaced with upgraded cases for evaluation.Actual units were not overheating.The site has a history of units overheating with incorrect battery insertion.

Manufacturer Narrative

H10: additional narrative: complaint states nkc technician performed case upgrades to telemetry transmitters that are getting reports of overheating.Service requested repair: rear case change.Service performed repair: rear case change.Investigation results: upon investigation it was determined that 10 transmitters had rear cases replaced with upgraded cases for evaluation.Actual units were not overheating.The site has a history of units overheating with incorrect battery insertion.Corrected information: f9.Approximate age of device: incorrectly calculated.Additional information: b4.Date of this report.F6.Date user facility/importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.Type of report.H2.If follow-up, what type? additional information.Correction.H6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

Event Description

It was reported that the transmitter got overheated.No consequence or impact to the patient.

• Brand Name: ZM-521PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 8233973
• MDR Text Key: 132810643
• Report Number: 8030229-2019-00013
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• Combination Product (y/n): N
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-521PA
• Device Catalogue Number: ZM-521PA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2019
• Distributor Facility Aware Date: 04/09/2019
• Device Age: 37 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2019
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 12/10/2018; 04/09/2019
• Supplement Dates FDA Received: 04/09/2019; 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1