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

Model Number ALLURA XPER FD20

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2021

Event Type  malfunction  

Event Description

It was reported to philips that the table top free floated when transferring the patient from the table to the bed.The customer has reported that this nearly caused a safety incident when moving the patient.It was reported that this problem occurred multiple times.No harm to patient or user has been reported to philips.Philips has started an investigation for this complaint.Based on the investigation, individual mdrs for each patient may be submitted.

Manufacturer Narrative

Philips has investigated this complaint.Philips has completed a good faith effort to get further information on the reported incident and if multiple patients were involved.However, the customer has confirmed that they will not provide information.A philips engineer inspected the system onsite and analyzed the log file.The log file showed a table brake error that caused a geometry restart and the release of the brakes of the tabletop.Whenever the brakes of the table are released, the tabletop free floats.The brake assy lateral movement, lateral double brake assy ad7 and the brake 40x40 ul were replaced and the system was returned to use in good working order.

• 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: 11391371
• MDR Text Key: 234226525
• Report Number: 3003768277-2021-00021
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00884838059054
• UDI-Public: 00884838059054
• 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: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD20
• Device Catalogue Number: 722012
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/12/2021
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1