MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. INGENUITY CT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Catalog Number III

Device Problem Human-Device Interface Problem (2949)

Patient Problem Abrasion (1689)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that during a patient procedure, the patient was lying prone, feet first on the patient table, the table was lowered, and the patient's foot was jammed between the gantry and table foot extension, which resulted in the patient being injured.A philips clinical applications specialist (cas) confirmed that the (b)(6) patient was injured.The customer's report, regarding the incident, stated that the patient only spoke (b)(6) and the operator could not understand her until the patient's granddaughter was brought in and then the operator raised the table to release the patient's toes.

Manufacturer Narrative

(b)(4).On (b)(6) 2015, the customer reported that prior to starting the patient procedure, the patient was lying prone, feet first on the patient table, with the patient¿s foot hanging from the end of the table foot holder.When the table was lowered, the patient¿s big toe was jammed between the gantry and table foot extension, resulting in an abrasion.A philips clinical applications specialist (cas) confirmed that the (b)(6) patient was mildly injured.When the operator realized that the patient's toe was jammed, the operator moved the patient support upwards to release the patient's toes.The cas confirmed that the patient was taken for additional observation of the injury to her toes.The operator contacted philips help desk to inform them of the event.The hospital also provided a report of the event to philips.The customer¿s report on the incident stated that the patient only spoke samoan and the operator could not understand her until the patient¿s granddaughter was brought in and then the operator raised the table to release the patient¿s toes.The additional observation of the patient's toes for confirming the extent of the injury showed that there was a minor abrasion and no additional treatment was necessary for it.The cas reported that the staff was retrained on the safe use of the patient table.The report also stated that since the patient did not speak or understand english and the patient¿s family members were not in the scan room to translate, there was a communication issue between the operator and the patient, which led to the incident.Based on the customer's report of the incident, engineering determined this issue was due to use error.Engineering reviewed this issue and determined that this event is acceptable risk.If this malfunction were to recur and the patient's body parts would be trapped between the gantry and the accessories due to use error, it would not be likely to cause death or serious injury because: design mitigations for prevention of the hazardous situations: - stopping horizontal motion in the presence of resistance force - table collision envelope - planning a scan beyond surview limits towards the in direction is limited to 100mm out of the surview boundaries.In addition, in case the plan box is out of surview boundaries in the in direction by any value between 20 to100mm, a warning to the user is displayed, in the current language, to watch the patient.This shall include planning a continued scan design mitigations enabling human response: - continuous activation for manual motion - emergency stop controls enable termination of motion in hazardous condition - table motion controls located on the gantry on the gantry and as foot pedals contributing to visual contact with the patient - recommended site planning provides means for visual contact with the patient - speed of motorized non-programmed motion is limited - free float of the table permits the user to load or unload the patient while maintaining visual contact with the patient.(applicable for horizontal) - for inward scans not planned on surview, exceeding the surview limits or requires significant couch travel to start position; the system requires the operator to enable automatic couch motion in preparation for the scan.- for inward scans not planned on surview, scans that exceed the surview limits or scans that require significant couch travel to start position, a warning message is displayed to the user.- restraining straps helps keeping the patient secure (also to the infant cradle) guidance: - instructions for use (ifu) warning to watch the patient during all movements - ifu warning to watch for collision of the infant cradle with the gantry covers during motion.The customers were re-trained on the proper use of the system.There was no malfunction of the ct system.The operator did not watch the patient's movement and lowered the patient support, thereby entrapping the patient's foot.

• Brand Name: INGENUITY CT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• Manufacturer Contact: nancy drake ; 595 miner rd; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 5078967
• MDR Text Key: 26184692
• Report Number: 1525965-2015-00242
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K033326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: III
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 77 YR