MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number ALLURA XPER FD10

Device Problems Positioning Failure (1158); Device Dislodged or Dislocated (2923)

Patient Problem Hematoma (1884)

Event Date 11/10/2020

Event Type  Injury  

Event Description

It has been reported to philips that after finishing a cardiac arrhythmia procedure, while the patient was being transferred, the patient fell to the floor.Patient suffered bruising and hematoma, and was hospitalized for observation.Philips has started an investigation for this complaint.

Event Description

Follow up: philips has investigated this complaint.Philips collected additional information.According to it, the table pivoted at the start of the procedure while transferring the patient from the bed to the table.As a result, the patient fell on the floor.Philips has confirmed that the patient suffered bruising and hematoma.A ct scan was performed and no other complications were observed.The philips ad7 table is designed to stay in place by means of a pivot brake, but also move when sufficient force is applied, so as not to injure hospital staff trying to move the table.Philips has inspected the site during planned maintenance in october 2020, prior to this incident.It was identified that the friction force of the pivot brake was not within specification.Philips informed the customer that a follow-up maintenance was required to resolve the problem.The customer accepted and continued using the system.After the occurrence of the reported incident (b)(6) 2020) the follow-up maintenance took place (b)(6), 2020).The pivot friction pad was cleaned and adjusted towards the upper limit of the specification.Additionally, the pivot brake was replaced proactively.The system was tested and returned to use in good working order with no reoccurrence of the issue.No similar complaints have been identified.

• Brand Name: ALLURA XPER FD
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• MDR Report Key: 10858741
• MDR Text Key: 216842316
• Report Number: 3003768277-2020-01026
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838059030
• UDI-Public: 00884838059030
• Combination Product (y/n): N
• PMA/PMN Number: K130842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD10
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/11/2020
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 76