MAUDE Adverse Event Report: SPAN AMERICA MEDICAL SYSTEMS, INC. PRESSUREGUARD PROTOCOL; ALTERNATING PRESSURE AND LAL MATTRESS

Model Number M69212

Device Problem Air Leak (1008)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 07/22/2017

Event Type  Injury  

Manufacturer Narrative

Upon opening the mattress, we found the low air loss (lal) airline inside of the mattress not connected to anything and missing the yellow fitting.This line is what connects to the yellow fitting exiting the pump and is solely used to send air constantly to the cover for moisture removal.We found that yellow fitting on the inflation system airline (clear tubing).It appears the white male fitting that came with the mattress had been cut off and replaced with the yellow male fitting.Once the two yellow fittings were reconnected, in this scenario, this failure mode is possible.We are working with the user facility to try and identify exactly why they went into the mattress and made these modifications.

Event Description

The patient was lying on the mattress and was pushed out of bed due to billowing of the surface.The patient fell and had a deep laceration to the left eyebrow area which required sutures.The patient returned from the doctor the same day.

• Brand Name: PRESSUREGUARD PROTOCOL
• Type of Device: ALTERNATING PRESSURE AND LAL MATTRESS
• Manufacturer (Section D): SPAN AMERICA MEDICAL SYSTEMS, INC.; 70 commerce center; greenville SC 29615
• Manufacturer (Section G): SPAN AMERICA MEDICAL SYSTEMS, INC.; 70 commerce center; greenville SC 29615
• Manufacturer Contact: william darby ; 70 commerce center; greenville, SC 29615 ; 8646786936
• MDR Report Key: 6789210
• MDR Text Key: 82534455
• Report Number: 1041130-2017-00002
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M69212
• Device Catalogue Number: M69212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2016
• 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
• Patient Age: 81 YR
• Patient Weight: 59