MAUDE Adverse Event Report: POSEY PRODUCTS LLC INVACARE MATTRESS; PATIENT BED WITH CANOPY/RESTRAINTS

Model Number RP8070M

Device Problem Dent in Material (2526)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Customer confirmed will not be returning product.Without the device the reported issue could not be confirmed and possible causes of the failure could not be determined.Historical review of the complaint database did not find any other related event.However, this product is a serviceable item that had been in use for several years without any maintenance performed.It's possible the reported issue is related to normal wear and tear.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use (ifu) were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warrant.Manufacturer reference file # (b)(4).Product will not be returning.

Event Description

Guardian reported the patient was found stuck between the mattress and the bed frame.It was noted the mattress was sunken in.It was confirmed the patient did not suffer any injuries from this event.The date the issue was discovered is unknown.

• Brand Name: INVACARE MATTRESS
• Type of Device: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck rd; arcadia CA 91006
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 8582896
• MDR Text Key: 144160904
• Report Number: 2020362-2019-00124
• Device Sequence Number: 1
• Product Code: OYS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2019

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: RP8070M
• Device Catalogue Number: RP8070M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1