MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE LP OTTOBOCK HARMONY® P4 HD MECHANICAL PUMP; 4R181 HARMONY® P4 HD MECHANICAL PUMP

Model Number 4R181

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problems Joint Dislocation (2374); Collapse (2416)

Event Date 03/12/2019

Event Type  Injury  

Event Description

As reported by the prescribing / fitting practitioner ((b)(6)), "we recently had a patient being fit with a p4 pump.During the test fit phase, our technicians had scratched up the top of the mounting plate in order to give it more bonding surface area.The mounting plate was attached to the socket using fab tec two part resin.Then the plate and socket were bonded together with fiberglass wrap.The patient left our facility and later that night the mounting plate completely separated from the socket.Unfortunately, the patient fell and dislocated his shoulder.".

• Brand Name: OTTOBOCK HARMONY® P4 HD MECHANICAL PUMP
• Type of Device: 4R181 HARMONY® P4 HD MECHANICAL PUMP
• Manufacturer (Section D): OTTO BOCK HEALTHCARE LP; 3820 west great lakes drive; west valley city UT 84120
• Manufacturer (Section G): OTTO BOCK HEALTHCARE LP; 3820 west great lakes drive; west valley city UT 84120
• Manufacturer Contact: stephen anderson ; 3820 west great lakes drive; west valley city, UT 84120 ; 8019746676
• MDR Report Key: 8551262
• MDR Text Key: 143239251
• Report Number: 1721652-2019-00002
• Device Sequence Number: 1
• Product Code: ISP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 4R181
• Device Catalogue Number: 4R181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 127