MAUDE Adverse Event Report: NATUS MEDICAL INC IP-HD-EC-VIDEO-EXT

Model Number IP-HD-EC-VIDEO-EXT

Device Problem Device Fell (4014)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/15/2022

Event Type  malfunction  

Manufacturer Narrative

Initial report ref to natus complaint (b)(4).The customer reported that the arm of a ergojust cart holding the monitor and camera fell and hurt a nurse.The customer stated they didn't seem loose when it fell off.The adverse event questionnaire was sent to the tech service for the customer.The customer returned the questionnaire.Per questionnaire, the customer reported the staff was transporting the equipment to the patients room when the arm of the cart holding the device's screen and camera broke, and hitting the staff on the lower right arm.The injured staff sought medical attention.Technical service requested images of the damaged cart and staff injuries if possible.Risk analysis and further investiagtion is ongoing.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.No complaint trends have been identified.

Event Description

It was reported that the arm of the cart fell and hit a nurse on the arm.The nurse was transporting equipment to a patients room at the time of the incident.The nurse sought medical attention for a lower right arm injury.

Manufacturer Narrative

Follow up report 002 ref to natus complaint# (b)(4).Qms-002413 rev 03 dated 11 may 22 documents the folllowing investigation results: video extension was returned intact, none of the welds at the base of the assembly were broken.The slot nuts were not installed into the slots on the cart per proper assembly procedures.If the nuts were installed in the slots the entire mast would need to be lifted until the nuts were clear of the slots for it to potentially fall.If the screws came out of the nuts the mast could also fall, but the nuts then fall down into the slots and are not easily retrievable.The wear on the nuts and the mast from pictures sent by the customer further confirms that the nuts were outside of the slots.The investigation concluded that the root cause/probable cause was an inproper installation of the mast.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.Service repair investigations will be conducted during the repair process and trend data will be reviewed per (b)(4).Faillure confirmed: yes.Investigation result code: neuro sbu|assembly error.Closure rationale: complaint verified, being tracked as a trend.Based on evaluation of this complaint there is no safety risk of harm, individual complaint related to issue stated.Complaint will be included in trending data for further review and investigation if needed.

Manufacturer Narrative

Follow up report 001 ref to natus complaint# (b)(4).Section d4 updated ref ip-hd-ec-video-ext, udi: (b)(4).The customer provided photos of the damaged cart and arm.The customer is unable to provide photos of the nurse's injury.Case tpi-2455 was created for engineering review.Acceptable risk associated with the complaint as per line 6.11 in doc-010378 xltek eeg psg risk analysis spreadsheet.No death or serious injury, considered a customer inconvenience.Manufacturing date: nov-22-2019.Install date: feb-13-2020.Investigation still ongoing.

• Brand Name: IP-HD-EC-VIDEO-EXT
• Type of Device: IP-HD-EC-VIDEO-EXT
• Manufacturer (Section D): NATUS MEDICAL INC; 2568 bristol circle; oakville, ontario CA L6 H 5S; CA CA L6H 5S1
• Manufacturer (Section G): NATUS MEDICAL INC; 2568 bristol circle; oakville, ontario CA L6 H 5S; CA CA L6H 5S
• Manufacturer Contact: emma noone ; ida business park; gort, galway H91PD-92 ; EI H91PD92
• MDR Report Key: 13888797
• MDR Text Key: 287818577
• Report Number: 9612330-2022-00015
• Device Sequence Number: 1
• Product Code: OMB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IP-HD-EC-VIDEO-EXT
• Device Catalogue Number: IP-HD-EC-VIDEO-EXT
• Device Lot Number: 187927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2019
• 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): Hospitalization