MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS INVIVO; SHOULDER ARRAY COIL SMALL

Model Number 453530030461

Device Problem Mechanical Problem (1384)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 12/23/2021

Event Type  Injury  

Event Description

Patient heating of shoulder occurred.

Manufacturer Narrative

Investigation to be done, results to be provided when concluded.

Manufacturer Narrative

Conclusion the reported blistering can be explained by direct contact between the coil and the patient's skin.No padding was used to ensure sufficient distance between the coil and the patient's skin.Based on the provided information and tests performed at customer site in this case siemens.They could not determine the root cause of the heating of the patient shoulder with absolute certainty.It was stated in the questionnaire that there was no contact of the skin to the bore or coil.The patient stated that they tensed up during the examination and raising their shoulders when being moved into the scanner, which might possibly lead to a contact to the coil.The appearance of the injury corresponds to the characteristics of a burn which is typically caused skin-to-coil contact.Since the qa of the coil confirmed that the coil is in specification a skin-to-coil contact is the most likely explanation for the burn.Several requests were made to receive more information to investigate this issue, but no feedback was received, no further requests will be made to acquire the necessary information.The investigation will be limited to the available data only.No related incidents are reported after this event.Therefore it was decided to close this complaint.A complete description of methodology (ies) used investigation according to our complaint handling process, including interviewing hospital staff.Evaluation of the risk management file based on available known information related to the incident.A technical assessment and log file analysis of the specific device was performed.Root cause analysis using ishikawa diagram (fishbone cause and effect, see (dep 109031).Information received: patient heating questionnaire (see attachment ¨patient_heating_questionnaire¨) patient age: (b)(6).Patient weight: 63.5 kg.Patient length: 6 in.Bmi: date and time of the examination: (b)(6) 2021 at 14:20 the patient was wearing his own clothing.No padding was used no padding was used to avoid skin-to-skin contact.No padding was used to avoid cable-to-skin contact.No padding was used to avoid body-to-bore wall contact.No information if patient was covered by a sheet or not.No information about patient ventilation used no (medical) conditions as listed within the patient heating questionnaire were found to be applicable to the patient.The patient was responsive and able to use the nurse call.The patient did not press the nurse call.No information about patient monitored was provided.The patient reported a skin reddening and blistering.Afterwards pictures were made, see attached.The left shoulder was injured.It is expected the injury will heal completely.The cable crossed the affected area.There was some sheet of paper between the cable and the body part.There was no skin-to-skin contact at the location of the injury: the shoulder wasn't in contact with coil on entering the scanner.She stated that she "tensed up" when tech put her in, raising her shoulders.There was no potential for body-to-bore wall: the shoulder wasn't in contact with coil on entering the scanner.She stated that she "tensed up" when tech put her in, raising her shoulders.The shoulder coil small, material number: 5516583 with serial number 7457.The coil was checked after the examination.Pictures ¿burnphoto_1_25-12-21.Jpg, ¿burnphoto_2_25-12-21.Jpg¿ and burnphoto_3_05-01-222 shows that the patient reported about redness and a blister at the shoulder.Affected area was approx 7cm x 7cm, round shape, blister is between 2,5 to 3 cm in size received information from siemens: coil qa was in specification and anatomy of local coil does not relate to skin contact to coil cable etc.So defective coil can be excluded as part of the root cause analysis as per information received from siemens, there is no indication that the coil was returned to us.Siemens requested the coil, but that request was completely unanswered by customer.Siemens report (pm00311668) shows: examination time: 24.9 min operating mode: normal mode rf-on time: 19.1167 min rf-load: 84.2 % sed: 28.8682 w min/kg sar values were below the limit of 2 w/kg during the whole examination anatomy scanned: shoulder patient positioned: head first, supine coil connected: shoulder coil small, material number: 5516583, serial number:(b)(6).The coil 12nc is shoulder array coil small (453530030461.Based on the above information the relevant parts of the fishbone diagram are (dep109031): system coil patient screening patient condition patient positioning environmental conditions methodology failure mode investigation: system the system was checked and no relevant malfunction was encountered.The problem could not be reproduced and the system was returned to use for the customer.Coil it was stated that the coil became warm after the examination.The coil was tested after the event and no malfunction was identified.The problem could not be reproduced.Patient screening the patient wore his own clothing patient condition no abnormalities observed in the provided information.Patient positioning the patient was positioned head first, supine.Environmental conditions no information is provided methodology examination time: 24.9 min operating mode: normal mode rf-on time: 19.1167 min rf-load: 84.2 % sed: 28.8682 w min/kg sar values were below the limit of 2 w/kg during the whole examination anatomy scanned: shoulder patient positioned: head first, supine coil connected: shoulder array coil small (453530030461) on behalf of the complaint handling unit mr (b)(6).

• Brand Name: INVIVO
• Type of Device: SHOULDER ARRAY COIL SMALL
• Manufacturer (Section D): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer (Section G): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14160985
• MDR Text Key: 289686527
• Report Number: 1056069-2022-00001
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838065741
• UDI-Public: 00884838065741
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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?: No
• Device Model Number: 453530030461
• Device Catalogue Number: 453530030461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 04/14/2022
• Supplement Dates FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 64 KG