MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NW AC SYSTEM, US; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number NWA1US1N

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 01/01/2021

Event Type  Injury  

Event Description

It was reported that during an unknown procedure, ct tech alerted me that they had a case in late 2021, exact date unknown right now but she is investigating, where the certus 140 caused their siemens scanner to shutdown completely.Certus 140 was set up within a few feet of the scanner.The pdm was clamped to bed plate on the ct scanner.This incident resulted in patient injury.As this has just been reported to me, the probe lot is unknown.The procedure was completed successfully.There was patient consequences.Patient had a 3rd degree burn and was treated for it.

Manufacturer Narrative

(b)(4).Batch #: unknown.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: what was the ablation procedure? how many probes were used? can a timeline of the events that occurred that are believed to led to the burn be provided? what is the alleged deficiency of the neuwave device that led to the patient burn and why are the two are connected? where was the location of the 3rd degree burn? what was the shape and size of the 3rd degree burn? how was the patient treated for the burn? are there any photos available? what is the patient's current status? an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.

Manufacturer Narrative

(b)(4).No call home data could be analyzed since no date range was given for this case.No further information was available.No further information was available.Service evaluated the system and confirmed no repairs were needed.The issue could not be verified.Complaint history was reviewed for this system, there are no other complaints against the system for this particular issue.Additional information was requested and the following was obtained: what was the ablation procedure? iliac bone ablation.How many probes were used? 3 pr probes.Can a timeline of the events that occurred that are believed to led to the burn be provided? access was gained through skin and muscle, 3 pr probes placed, early in the burn heat was felt at the skin, certus turned off.What is the alleged deficiency of the neuwave device that led to the patient burn and why are the two are connected? physicians believes no deficit in neuwave device, said 3 probes was too many.Didn't anticipate burn back.Where was the location of the 3rd degree burn? skin at patients hip.What was the shape and size of the 3rd degree burn? unavailable.How was the patient treated for the burn? taken to wound care immediately.Are there any photos available? unavailable.What is the patient's current status? unavailable, patient followed up at a different hospital.

• Brand Name: NW AC SYSTEM, US
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• Manufacturer (Section G): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo
• MDR Report Key: 14054544
• MDR Text Key: 288887642
• Report Number: 3008769756-2022-00015
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00853719006951
• UDI-Public: 00853719006951
• Combination Product (y/n): N
• PMA/PMN Number: K161285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

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: NWA1US1N
• Device Catalogue Number: NWA1US1N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 04/26/2022
• Supplement Dates FDA Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention