MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; RESUSCITATOR,MANUAL,ADLT,MASK,BAG RES

Catalog Number	CPRM1116
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a patient resuscitation event the swivel piece of the mask bag resuscitator broke off.The reported product issue occurred at the start of this event.A new mask bag resuscitator was obtained and the patient resuscitation event continued without further incident.The facility stated there was no impact or delay to the patient resuscitation event.There was no adverse effect noted or impact to the patient's stability.There was no change to the patient's plan of care.No serious injury, follow-up care, or medical intervention was reported.The sample was reportedly discarded and was not returned to the manufacturer for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a patient resuscitation event the swivel piece of the mask bag resuscitator broke off.

• Common Device Name: RESUSCITATOR,MANUAL,ADLT,MASK,BAG RES
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7389539
• Report Number: 1417592-2018-00020
• Device Sequence Number: 1274406
• Product Code: NHK
• UDI-Device Identifier: 10884389125120
• UDI-Public: 10884389125120
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CPRM1116
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR