MAUDE Adverse Event Report: INVACARE CORPORATION POSITION RECLINER/GERI CHAIR; CHAIR, ADJUSTABLE, MECHANICAL

Model Number 6905A

Device Problem Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 01/22/2017

Event Type  Injury  

Event Description

It was noted that resident (b)(6) had dried blood on his geri-sleeves.The cna who witnessed this reported this immediately to the lpn who responded to inspect and noted that the tip of the resident's left third finger had been severed after transfer of the resident to the emergency department was complete, the nursing supervisor inspected the geri-chair and found the severed portion of resident (b)(6) finger adhered to the metal hinge under the seat of the chair.

• Brand Name: POSITION RECLINER/GERI CHAIR
• Type of Device: CHAIR, ADJUSTABLE, MECHANICAL
• Manufacturer (Section D): INVACARE CORPORATION ; 1 invacare way; worldwide headquarters; elyria OH 44035
• MDR Report Key: 6279050
• MDR Text Key: 65940852
• Report Number: MW5067468
• Device Sequence Number: 1
• Product Code: INN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6905A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR
• Patient Weight: 88