PROTON THERAPY DEVICE AT MCLAREN

Report

• Report Number: MW5098266
• Event Type: Malfunction
• Date Received: December 8, 2020
• Report Date: December 5, 2020
• Manufacturer: MCLAREN HEALTH CARE
• Product Code: LHN
• Product Problem: Yes
• Report Source: Voluntary report
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

MY RELATIVE WAS GETTING TREATED WITH PROTON THERAPY AT THE (B)(6) CENTER IN (B)(6), WHEN THE THERAPY EQUIPMENT CRASHED AND FELL ON HIM. HE WAS SCARED AND TERRIFIED WHEN THAT HAPPENED BUT THANKFULLY WAS NOT HURT SINCE HE WAS SAVED BY THE NARROW PASSAGE BETWEEN THE EQUIPMENT AND THE PATIENT BED. FDA SAFETY REPORT ID # (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1429107	PROTON THERAPY DEVICE AT MCLAREN	SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL	LHN	MCLAREN HEALTH CARE

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Clinical Signs, Symptoms or Conditions

Product problems · 1

• Device Fell

Type of report · 1

• Initial submission