INVACARE ELECTRIC 53011VC UNIVERSAL BED VC6840

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for INVACARE ELECTRIC 53011VC UNIVERSAL BED VC6840 manufactured by Invacare Corp..

Event Text Entries

[141568905] Motor fall off. Level falls down. The front of bed is short when head is put up, put a lot of pressure on spinal area. This product should not be used with a rod in back causes damage to spinal area. This bed will cause damage to spinal cord. My son has duchenne muscular dystrophy with a harrington rod to spinal. This bed doesn't support my son? S spine and caused a 5cm wound to lower back with pressure sore. He had an air mattress from drive. The bed still put too much pressure. I was trying to get hillrom hospital bed, i was denied from my insurance company (b)(6) eight times not medically necessity. My son had to go to the wound center three times a week for pre-sacral wound which eroded due to pressure from his spinal rod on his current bed. Possible plastic surgery intervention.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5085686
• MDR Report Key: 8496915
• Date Received: 2019-04-08
• Date of Report: 2019-04-01
• Date Added to Maude: 2019-04-09
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: INVACARE ELECTRIC 53011VC UNIVERSAL BED
• Generic Name: BARIATRIC BED
• Product Code: OSI
• Date Received: 2019-04-08
• Model Number: VC6840
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INVACARE CORP.

Device Sequence Number: 2

• Brand Name: INVACARE ELECTRIC 53011VC UNIVERSAL BED
• Generic Name: BARIATRIC BED
• Product Code: OSI
• Date Received: 2019-04-08
• Model Number: VC5000
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: INVACARE CORP.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-04-08