DEVILBISS 7305 SUCTION UNIT 7305PD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-01 for DEVILBISS 7305 SUCTION UNIT 7305PD manufactured by Devilbiss.

Event Text Entries

[59204954] Biomedical tech performed annual preventative maintenance on devilbiss 7305 suction unit. During maximum vacuum test (suction line occluded to generate maximum suction in canister), disposable suction canister imploded leading to catastrophic failure with plastic pieces ejecting outwards. Subsequent inspection revealed that the canister lid had severely embrittled, causing the failure. Inspection of two other devilbiss suction units in the lower mainland revealed that their lids were also embrittled. Relatively small amount of force generated by pressing on the canister lots caused them to crack. The part number 614700 was printed on the front of the affected canisters. Inquiry with devilbiss indicated that these canisters were manufactured by bemis. Historically, devilbiss 7305 pd units were sold with bemis canisters. Communications with bemis revealed that the affected canisters (part number 614700) have a 36 month shelf life. There is no evidence to show that this shelf life was ever stated by devilbiss to the consumer. Thus, the end-user of the suction device would not be aware that the disposable canister has a shelf life. Devilbiss units are used in hospital often only in emergency situation where wall suction is not available, or when wall suction fails. These situations rarely occur. Resultantly, many units have never been seen clinical use. The disposable bemis canisters which were initially shipped with the device have in many cases never been replaced. Devilbiss now manufactures their own disposable canisters in-house that have an unlimited shelf-life. There is significant concern; however that older devilbiss units could still have their original bemis canisters. These canisters have most likely expired years ago and are prone to failure due to debridement of the lids. Failure of the suction unit in an emergency scenario is the worst possible time failure could occur.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5065772
MDR Report Key6075286
Date Received2016-11-01
Date of Report2016-11-01
Date of Event2016-09-13
Date Added to Maude2016-11-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDEVILBISS 7305 SUCTION UNIT
Generic NameDEVILBISS 7305 SUCTION UNIT
Product CodeEBR
Date Received2016-11-01
Model Number7305PD
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDEVILBISS


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-11-01

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