FOHClass I

Mattress, Water, Temperature Regulated

General Hospital · 21 CFR 880.5560

MDR events18All time

Recalls0All time

Registered firms6Currently listed

510(k) clearances6All time

Recent MDR events

18 adverse event reports on file

TCMATTJul 9, 2025
MalfunctionTec Com Medizintechnik Gmbh22456456
ZOLL INNERCOOL STX SURFACE SYSTEMOct 16, 2023
MalfunctionZoll Circulation3010617000-2023-00872
STX SURFACE COOLINGSep 6, 2019
InjuryZoll Circulation, Inc.3010617000-2019-00780
STX SURFACE COOLINGJul 26, 2019
InjuryZoll Circulation, Inc.3010617000-2019-00653
PHILIPSApr 2, 2014
MalfunctionPhilipsMW5035473
ISOFLEX MEDSURG MATTRESS MODELJun 30, 2011
InjuryStryker Corp Dba Gaymar1313850-2011-00157
TEMPERATURE THERAPY PADJun 14, 2011
MalfunctionStryker Corp Dba Gaymar1313850-2011-00139
TEMP PUMP TEMPERATUREJun 14, 2011
MalfunctionStryker Corp Dba Gaymar1313850-2011-00140
TEMPERATURE THERAPY PADJun 14, 2011
MalfunctionStryker Corp Dba Gaymar1313850-2011-00141
TEMP PUMP TEMPERATUREMay 27, 2011
MalfunctionStryker Corp Dba Gaymar1313850-2011-00119

Event type breakdown

Malfunction11

Injury6

Unspecified1

Most-reported manufacturers

Stryker Corp Dba Gaymar9 Zoll Circulation, Inc.2 Unspecified1 Cooper Surgical1 Gaymar Industries, Inc.1 Gaymer Industries, Inc.1 Philips1 Tec Com Medizintechnik Gmbh1

Recalls

0 recall events for this product code

No recalls on file for this product code.

Registered firms

6 firms currently registered for this product code

510(k) clearances

6 clearances for this product code