MAUDE Adverse Event Report: PHILIPS HEALTHCARE POLY G (FLOOR)-LARC-OMCP-VISUB-CCD; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 72247

Device Problem Component Falling (1105)

Patient Problems Hematoma (1884); Injury (2348); No Code Available (3191)

Event Date 09/05/2014

Event Type  Injury  

Event Description

Philips received a complaint from a customer that monitor suspension fell to ground causing injury to user.During preparing for case, when relocating the monitor suspension, it fell on top of a doctor causing injury.Hematoma on head, broken finger and possible damage to c5 spine.

Manufacturer Narrative

(b)(4).When investigation is completed a follow up report will be sent to the fda.

Manufacturer Narrative

The fallen monitor suspension has been analyzed on site by philips health care product specialists.The cause of the monitor suspension fell to the ground was two missing bolts in the side plate in combination with rough handling due to rail wear.This caused high forces on the two present bolts in the side plate which eventually broke and caused the monitor suspension fell to ground.The root cause for the two missing bolt is because the distance between the side plates of the yoke had become bigger than the length of the suspension axis.This distance increased due to the breaking of bolts a1 and a2, which was caused by bolts b1 and b2 missing, in combination with the higher forces, due to wear of the bearing surface of the ceiling rail.Parts that are connected to the monitor suspension were removed and placed in holding at the request of the customer.A different monitor suspension was replaced.The system is in used normally.(b)(4).

• Brand Name: POLY G (FLOOR)-LARC-OMCP-VISUB-CCD
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; best 5680 DA; NL 5680 DA
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best ; NL
• Manufacturer Contact: dominic siewko ; 3000 minuteman rd, ms 4-235; andover, MA 01810 ; 9786597936
• MDR Report Key: 4112889
• MDR Text Key: 4838678
• Report Number: 3003768277-2014-00102
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72247
• Device Catalogue Number: 72247
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/05/2014
• Initial Date FDA Received: 09/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1