MAUDE Adverse Event Report: INNOVATIVE PRODUCTS UNLIMITED SHOWER CHAIR COMMODE; HYGIENE ASSIST DEVICE

Model Number SCC9250 MS

Device Problems Component Falling (1105); Device Slipped (1584); Noise, Audible (3273)

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

Event Date 06/16/2017

Event Type  malfunction  

Event Description

From nurse manager: two caregivers assisted patient onto the commode.When sitting, the seat came free.It slid out the back and fell to the floor.Leaving the patient sitting on one crossbar.Staff were worried the single bar would break as it was making a creaking sound.Additional help arrived and the patient was assisted back to bed without incident.The patient was well under the weight capacity.The commode was removed from service at this point.Manufacturer response for bedside commode, (brand not provided) (per site reporter): i spoke to a company representative and he is sending a replacement, and i will be sending the commode back for investigation.I also requested the paperwork that comes with the commode when initially purchased.

• Brand Name: SHOWER CHAIR COMMODE
• Type of Device: HYGIENE ASSIST DEVICE
• Manufacturer (Section D): INNOVATIVE PRODUCTS UNLIMITED; 2120 industrial dr.; niles MI 49120
• MDR Report Key: 6680103
• MDR Text Key: 78813764
• Report Number: 6680103
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SCC9250 MS
• Device Catalogue Number: SCC9250 MS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO