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U.S. Department of Health and Human Services


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Model Number CPRM1116M
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The affected product had a patient valve which is used on many resus products. Thirteen valves were removed from inventory and tested one at a time with a k-resin mask. The valve was held in one hand and the mask was held in the other. Every reasonable attempt was made to break the patient valve off. None of the valves broke. The customer returned one affected device in a biohazard bag. The patient port and the mask were missing. The patient valve did not exhibit any damage even though the patient port was missing. This affected device utilized a patient valve (p/n 402114 lot 161000117) and mask (p/n 205104 lot 16090064). The patient valve was received on 11/29/2016 which means it had a pet patient port and the improved c-ring design. The mask was received on 10/13/2016 which means it had a k-resin cone. To the investigator's knowledge, this is the first complaint for a patient port detaching with this combination of materials.
Event Description
The customer alleges "the patient port separated from the rest of the bag. " no other details were provided and no patient injury/harm reported.
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Type of DeviceRESUS BAG
Manufacturer (Section D)
2710 northridge dr.
suite a
grand rapids MI 49544
Manufacturer (Section G)
2710 northridge dr.
suite a
grand rapids MI 49544
Manufacturer Contact
carrie fortuna
2710 northridge dr.
suite a
grand rapids, MI 49544
MDR Report Key6674072
MDR Text Key78700768
Report Number2246980-2017-00022
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 06/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCPRM1116M
Device Lot Number308026
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage