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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. PANDA IRES WARMER WARMER, INFANT RADIANT

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DATEX-OHMEDA, INC. PANDA IRES WARMER WARMER, INFANT RADIANT Back to Search Results
Device Problem Material Integrity Problem (2978)
Patient Problem Insufficient Information (4580)
Event Date 12/14/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). No report of patient involvement. Ge healthcare (gehc) reported a field modification for this issue per 21 cfr 806 on 20 march 2019. The fda recall number is z-1846-2019 & z-1847-2019. - customers were sent a letter explaining the issue and requesting the customer to inspect the warmer bedside panel latch areas. Replacement of broken bedside panels will be provided by gehc. - a set of warning labels will be supplied for application to the bedside panels. These labels will warn the user to not use the bedside panels for maneuvering the warmer and indicate the correct method of maneuvering the warmer. - an addendum to the operation and maintenance manual will also be provided emphasizing the need to check and ensure that the bedside panels and latches are not cracked, broken, or damaged before every patient use. The addendum will also contain instructions to increase detectability of broken or cracked bedside panels. - on june 14, 2019 a letter was sent to customers providing an additional addendum, labels, and wall poster. (b)(4). No report of patient involvement. Ge healthcare (gehc) reported a field modification for this issue per 21 cfr 806 on 20 march 2019. The fda recall number is z-1846-2019 & z-1847-2019. - customers were sent a letter explaining the issue and requesting the customer to inspect the warmer bedside panel latch areas. Replacement of broken bedside panels will be provided by gehc. - a set of warning labels will be supplied for application to the bedside panels. These labels will warn the user to not use the bedside panels for maneuvering the warmer and indicate the correct method of maneuvering the warmer. - an addendum to the operation and maintenance manual will also be provided emphasizing the need to check and ensure that the bedside panels and latches are not cracked, broken, or damaged before every patient use. The addendum will also contain instructions to increase detectability of broken or cracked bedside panels. - on june 14, 2019 a letter was sent to customers providing an additional addendum, labels, and wall poster.
 
Event Description
As a result of an inspection that was completed as part of correction and removal z-1846-2019 & z-1847-2019, this system was identified as having the broken latch and/or cracked wall malfunction.
 
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Brand NamePANDA IRES WARMER
Type of DeviceWARMER, INFANT RADIANT
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
jason kelly
3000 n grandview blvd.
waukesha, WI 
MDR Report Key11146335
MDR Text Key227629346
Report Number2112667-2021-00079
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Remedial Action Recall
Type of Report Initial
Report Date 01/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/14/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/26/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberSEEH10

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