MAUDE Adverse Event Report: SPAN AMERICA MEDICAL SYSTEMS, INC. PRESSUREGUARD PROTOCOL; POWERED AIR MATTRESS WITH CONTROL UNIT

Model Number P8035-29

Device Problem Inflation Problem (1310)

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

Event Date 10/29/2016

Event Type  malfunction  

Manufacturer Narrative

We cannot replicate the failure mode using the returned pressure guard protocol control unit (or any of our control units).The returned unit was functioning correctly and all safety features were in place.We have set the control unit in a worst case scenario (bypassing certain safety features) and still cannot reproduce the failure mode.The only way we were able to replicate the expanded tube was to attach "shop air" to the mattress fitting for 35+ seconds.This will produce the same failure mode described in the complaint and observed in the returned product.At this point, we do not see a product failure or problem but will continue our testing.

Event Description

The air mattress was over-inflated causing the patient to be pushed out of the bed.

• Brand Name: PRESSUREGUARD PROTOCOL
• Type of Device: POWERED AIR MATTRESS WITH CONTROL UNIT
• 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: 6135172
• MDR Text Key: 61454000
• Report Number: 1041130-2016-00003
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P8035-29
• Device Catalogue Number: P8035-29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1