MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED S4500 BEDSIDE UNIT W BRACKET

Model Number 2000304

Device Problem Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2023

Event Type  malfunction  

Event Description

The customer reported that s4500 bedside unit with bracket overheated and melted outside casing.They said it was observed that the device was getting very hot.The back of the casing seems to have started melting from the heat.No injuries reported.

Manufacturer Narrative

Initial report ref natus complaint (b)(4).Technical support requested customer to return entire camera system and provided shipping label.They also provided the ifu nicview manual to customer and requested they review the safety intended use instructions with staff.Ifu shows warning to "never mount directly over a baby" there are no capa's related to this issue.This complaint does not identify a deficiency in the product design and therefore a capa is not required.Per (b)(4), complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.Acceptable risk as per hazard id b1 in (b)(4) risk analysis for nicview.Risk is considered to be low.Severity level 3.A risk review is not required as this complaint does not describe a new failure mode or new harm and the existing hazard severity and/or probability of occurrence has not changed." udi#: not applicable.Ship date: 22-jun-2023.Further investigation to be carried out.

Manufacturer Narrative

Follow up report 001 ref natus complaint# (b)(4).With reference to the initial report, section h10 additional narrative/ data - the information provided at the time was incorrectly documented from a different case.See corrected data below: the customer provided pictures of the affected product and advised that they will return the affected product for investigation.There are no capa's related to this issue.This complaint does not identify a deficiency in the product design and therefore a capa is not required.Per qms-004442, complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.Acceptable risk as per hazard id 6.2, severity 3 in doc-013534 embla risk analysis.Risk is considered to be low.A risk review is not required as this complaint does not describe a new failure mode or new harm and the existing hazard severity and/or probability of occurrence has not changed.A dhr review is not applicable because, prior to the reported issue the device was in service for 2 or more years and a manufacturing defect is very unlikely further investigation to be carried out, pending product return.

Event Description

The customer reported that s4500 bedside unit w bracket overheated and melted outside casing.They said it was observed that the device was getting very hot.The back of the casing seems to have started melting from the heat.No injuries reported.

Manufacturer Narrative

Follow up report 002 ref natus complaint# (b)(4).Natus received the suspected device back.The evaluation details noted the following: "visual inspection: housing paint is peeling likely due to wear and prolonged/frequent exposure to cleaning chemicals.There are small cracks in the housing bottom corners.Multiple pin collars broken.Multiple pins covered in crusted residue.Cradle was dismantled by customer.Functional testing: unit connected to test unit using dismantled cradle that came with the unit.Unit powers up and recognizes oximeter input.Unit does not pass impedance test.Ran functional test.Noise on f4, thermistor, and position.Ran test overnight.No excessive heating observed.Post testing observation: opened unit, broken f4 and oximeter collars fell out.No evidence of internal damage due to overheating.Conclusion: it is not likely that the unit overheated.Paint peeling is a commonly observed problem with bedside units.Artifacts described in the adverse event questionnaire are most likely due to worn and broken pin collars causing unstable connections." a device history record review is not applicable because, prior to the reported issue the device was in service for 2 or more years and a manufacturing defect is very unlikely.Install date: 18-dec-2017.Faillure confirmed: no investigation result code: neuro sbu|physical damage complaint will be included in trending data for further review.

Event Description

The customer reported that s4500 bedside unit w bracket overheated and melted outside casing.They said it was observed that the device was getting very hot.The back of the casing seems to have started melting from the heat.No injuries reported.

• Brand Name: S4500 BEDSIDE UNIT W BRACKET
• Type of Device: S4500 BEDSIDE UNIT W BRACKET
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios, l6h 5s1, ; CA
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios l6h 5s1, ; CA
• MDR Report Key: 17610350
• MDR Text Key: 321814248
• Report Number: 9612330-2023-00032
• Device Sequence Number: 1
• Product Code: MNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2023

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: 2000304
• Device Catalogue Number: 2000304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 08/17/2023; 08/17/2023
• Supplement Dates FDA Received: 09/13/2023; 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• 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