MAUDE Adverse Event Report: MAQUET SAS MODUTEC; TUBING, PRESSURE AND ACCESSORIES

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On 8th of may 2020 getinge became aware of an issue with one of our device ¿ modutec.As stated by the customer when pushing the table during the surgery operator lose control on it allowing to collide with the modutec device.Due to mentioned situation modutec device has been damaged and paint chipping on the device¿s shelve has been discovered.No injury has been reported due to mentioned issue however we decided to report it in abundance of caution as any particles transferred into sterile field might be a source of contamination.Manufacturer's reference number (b)(4).

Event Description

Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of our device ¿ modutec.As stated by the customer when pushing the table during the surgery operator lose control on it allowing to collide with the modutec device.Due to mentioned situation modutec device has been damaged and paint chipping on the device¿s shelve has been discovered.No injury has been reported due to mentioned issue however we decided to report it in abundance of caution as any particles transferred into sterile field might be a source of contamination.It was established that when the event occurred, the device did not meet its specification (paint was chipping) and it contributed to incident.In the time when the event occurred the device was being used for patient treatment.When reviewing similar reportable events for the same device, we have been able to establish that is single and isolated event on modutec device.According to subject matter experts, the damages occurred due to impacts and collisions (abnormal use).To prevent any similar incident, it is recommended to avoid the collisions between devices.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.Corrected data: additionally the purpose of this submission is solely to provide a correction of describe event or problem section.This is based on the result of an internal review noting the report was incorrectly submitted with incorrect date.#b5: previous:on 8th of may 2020 getinge became aware of an issue with one of our device ¿ modutec.As stated by the customer when pushing the table during the surgery operator lose control on it allowing to collide with the modutec device.Due to mentioned situation modutec device has been damaged and paint chipping on the device¿s shelve has been discovered.No injury has been reported due to mentioned issue.Corrected data: on 7th of may 2020 getinge became aware of an issue with one of our device ¿ modutec.As stated by the customer when pushing the table during the surgery operator lose control on it allowing to collide with the modutec device.Due to mentioned situation modutec device has been damaged and paint chipping on the device¿s shelve has been discovered.No injury has been reported due to mentioned issue.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Issue is being investigated by manufacturing site.

• Brand Name: MODUTEC
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 10111175
• MDR Text Key: 194195754
• Report Number: 9710055-2020-00165
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1