MAUDE Adverse Event Report: INVACARE TAYLOR STREET NLA NO RPLMT APM MATTRESS ONLY-STANDARD 9153642131; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number BEDPRD

Device Problem Air Leak (1008)

Patient Problem Pressure Sores (2326)

Event Date 12/02/2011

Event Type  malfunction  

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.Technician took mattress to be repaired and did not leave another mattress.Lack of a mattress is alleged to have caused the bed sores.

Event Description

Technican found majestic apm mattress was leaking air and was rmoved to be repaired.Technician did not leave another mattress.Alleged that user incurred bed sores caused by the lack of a mattress.

• Brand Name: NLA NO RPLMT APM MATTRESS ONLY-STANDARD 9153642131
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5644220
• MDR Text Key: 44901250
• Report Number: 1525712-2016-01302
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BEDPRD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2014
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention