FDA.reportPublic FDA data

MAUDE MDR 7925415

MDR report key
7925415
Report number
7925415
Event key
0
Event type
3
Date of event
2018-08-19
Date received
2018-10-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COMPELLA AIR SUPPLYBARIATRIC BEDHILL-ROM, INC.OSI* R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-10-020

Event Narratives#

D

Patient 1

A RENTAL BED WITH LO-AIR LOSS PRESSURE SUPPORT MATTRESS "WERE" BROUGHT INTO THE PATIENTS ROOM. THE CORD FOR THE LO-AIR LOSS PRESSURE MATTRESS WAS PINCHED AGAINST THE MOVABLE PART OF THE BED FRAME. WHEN THE PATIENT WENT TO ADJUST THE BED, THE CORD WAS COMPRESSED AND CAUSED THE CORD TO SPARK AND SHORT. MANUFACTURER RESPONSE FOR COMPLELLA AIR SUPPLY, COMPELLA AIR SUPPLY (PER SITE REPORTER): THE RENTAL MANUFACTURER INSPECTED THE BED AND VERIFIED IT INDEED HAD A CRUSH/BRUISING THAT CAUSED THE POWER CORD TO SHORT AND SPARK.