MAUDE Adverse Event Report: INVACARE CORPORATION (TW) ALL-IN-ONE-ALUMINUM COMMODE 4 PER CARTON 9153637754; ADAPTOR, HYGIENE

Model Number 9650

Device Problem Collapse (1099)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2019

Event Type  malfunction  

Event Description

The phlebotomist called out that patient was "folded" in the commode.Patient had gotten out of bed without assistance because she "didn't want to bother anyone".Bed alarm was not activated.Patient was using bedside commode and it collapsed underneath her.Patient was assessed by rn then pa and patient was free of injury.Bedside commode had a bar that popped out of it causing it the bucket to fall through.Commode taken out of service.

• Brand Name: ALL-IN-ONE-ALUMINUM COMMODE 4 PER CARTON 9153637754
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): INVACARE CORPORATION (TW); 39400 taylor pkwy; north ridgeville OH 44035
• MDR Report Key: 8439205
• MDR Text Key: 139418213
• Report Number: 8439205
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2019

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: No Information
• Device Model Number: 9650
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33215 DA